Senior Medical Director Resume Samples

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L Cummings

Lily

Cummings

1251 Bartoletti Plains

Boston

+1 (555) 849 0076

1251 Bartoletti Plains

Boston

Phone

p +1 (555) 849 0076

Experience Experience

Los Angeles, CA

Senior Medical Director

Los Angeles, CA

Tillman, Gaylord and Raynor

Los Angeles, CA

Senior Medical Director

Develop global medical affairs plan for product life cycle management
Responsible for timely execution of medical affairs plan within budget
In cooperation with affiliate / regional medical teams, marketing, regulatory, clinical and other functional areas, provides leadership, oversight and support for assigned products/projects
Collaborate with internal stakeholders (R&D, commercial, regional medical teams) and external stakeholders (key opinion leaders, advocacy and cooperative groups)
Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders)
Represent AbbVie at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with key opinion leaders
Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global concepts/protocols and their reports across different products

San Francisco, CA

Senior Medical Director Mltss

San Francisco, CA

Douglas Inc

San Francisco, CA

Senior Medical Director Mltss

Collaborate with CMO, Medicaid and Behavioral Services and engage all functional areas of MLTSS from a clinical perspective to develop innovative programs as well as products lines; serving as the primary clinical liaison with Network Services, Strategic and Advisory Services, Finance and Underwriting, Marketing, Operations, Information Systems, Pharmacy, and Product Development
Nurture personal and professional growth/development by attending seminars, workshops, and establishing professional affiliations to keep abreast of latest trends in field of expertise
Interface with UPMC Health System cross-functional and shared resources to further the 'cause' to create a seamless healthcare patient-flow management process and insurance model
Swiftly respond to challenges and/or opportunities as they arise. Develop and implement innovative programs to act on historical data, identifying new trends, retooling existing approaches, and analyzing the competition
As an integral member of UPMC Health Plan's leadership team, serve as a 'role model' and 'health advocate' within the Pennsylvania community, including active participation with UPMC sponsored activities, public events and community outreach programs
Collaborate with physicians to develop clinical programming by accessing and mining clinical data, devising methods to manage populations. Partner with physicians to improve reimbursement model and performance based physician incentive programs
As CHC and in particular UPMC expands its membership, motivate and mentor UPMC Health Plan's clinical and Medical Affairs staff by 'setting the pace' and fostering 'excellence by example'. Assess the overall team, including ongoing recruitment and hiring of talent. Ensure that the organization has the 'right people' in the 'right positions' and that the organization's structure is designed to maximize result

present

Chicago, IL

Senior Medical Director, Clinical Development

Chicago, IL

Reinger, Bergnaum and Olson

present

Chicago, IL

Senior Medical Director, Clinical Development

present

Provide oversight and contribute to the development of clinical protocols and amendments, investigator brochures, and clinical study reports
Establish and drive teams to execute the strategic long-term vision for a key pipeline drug candidate
Serve as the joint development committee clinical lead for partnered development programs
Contribute to the strategic development of other early and late stage clinical programs
Conduct literature reviews and prepare summaries to support clinical development programs
To interact with multiple levels of management within Biogen as well with regulatory authorities
Serve as a competent medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates

Education Education

Bachelor’s Degree in Medicine

Loyola University Chicago

Bachelor’s Degree in Medicine

Skills Skills

M.D., D.O
Board Eligible / Certified
M.D. or D.O
Strong clinical skills and knowledge
Unrestricted New York License
Board certification from American Osteopathic Association (AOA) or American Board of Medical Specialties (ABMS)
5+ years of clinical experience
5+ years of clinical practice experience
Patient-oriented
5+ years of experience as a managed care/health plan medical director

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Senior Medical Director Resume Examples & Samples

Strong clinical skills and knowledge
Unrestricted New York License
5+ years of clinical experience
5+ years of experience as a managed care/health plan medical director

Senior Medical Director Retiree Solutions Resume Examples & Samples

Ability to work closely with sales, marketing, account management, healthcare economics and market business and clinical leaders to develop the sales pipeline, respond to written proposals as well as present at finalist and renewal oral presentations that grow and maintain membership and long-term relationships
While providing that support, is facile with face-to-face or remote remediation discussions
Uses a data driven and experiential consultative approach with clients on analytics, assessment and potential solutions
Assists in the oversight, management and coordination of activities of UnitedHealthcare Medicare & Retirement, Employer & Individual with United Clinical Services, Quality Management Performance, Member Experience, OptumHealth, Optum Behavioral Health, other internal business partners and external vendors
Serves as an external expert spokesperson to communicate our clinical value story to audiences including public sector, labor & trust, national accounts, professional associations and other thought leadership events
Provides strategic input to quality, clinical programs, affordability and fraud and abuse teams
Develops deep knowledge of UHG resources and capabilities, including but not limited to HouseCalls and Optum solutions
Demonstrates expertise in CMS regulations, including the Star Ratings and Risk Adjustment
Ensures all aspects of clinical strategy at the account/plan level are executed and provides oversight and direction for the implementation of clinical programs and strategies
Maintains expertise in adult medicine, geriatrics, end-of-life care, regulatory guidelines and Medicare payment policy
Represents the CMO, Retiree Solutions as needed in national level committees and meetings setting medical necessity strategies
Serves as a subject matter expert in the development of business cases, ROI calculations for account specific clinical initiatives, clinical guidance to business leaders regarding appropriate utilization, improving outcomes while decreasing cost
Supports Star Ratings/HEDIS/CAHPS/HOS performance, accreditation and compliance programs and takes into account when developing clinical strategy
Participates in the development and execution of clinically integrated networks
Provides consultative advice to local network management regarding the medical delivery system, enhancement to services, provider patient care issues
Makes recommendations on solutions to leadership; resolution management
Manages tasks successfully and is self-directed
Fellowship training and/or certification in Geriatrics - preferred
5+ years clinical practice
5+ years in previous leadership positions
5+ years previous in managed care
Extensive record of performance, by meeting and exceeding operational goals in health care quality and cost management
Ability to develop lasting relationships with business partners, network and community physicians and other providers
Flexibility and positive attitude essential
Experience in population health management
Matrixed supervisory skills including clinical mentoring and coaching skills

Senior Medical Director Resume Examples & Samples

A minimum of an advanced degree in medicine (i.e. M.D or DO or equivalent) in relevant area with experience in clinical/drug development in infectious diseases is required
A minimum 5 years of experience designing, leading and managing significant clinical trials including infectious diseases in the pharmaceutical industry including early stage programs is required
Antiviral experience is preferred
This position is located in South San Francisco and may require 10-20% travel.Clinical Research MD

Senior Medical Director, Immunology Pipeline Resume Examples & Samples

Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports across different products
Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia
Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function

Senior Medical Director Resume Examples & Samples

Develop global medical affairs plan for product life cycle management
Responsible for timely execution of medical affairs plan within budget
In cooperation with affiliate / regional medical teams, marketing, regulatory, clinical and other functional areas, provides leadership, oversight and support for assigned products/projects
Collaborate with internal stakeholders (R&D, commercial, regional medical teams) and external stakeholders (key opinion leaders, advocacy and cooperative groups)
Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders)
Represent AbbVie at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with key opinion leaders
Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global concepts/protocols and their reports across different products
Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serves as the scientific team interface for key regulatory discussions
Ability to work independently. Can address complex problems within discipline or across several projects that require analysis of situation or in-depth evaluation of various complex factors. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions

Senior Medical Director, Oncology Resume Examples & Samples

Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned
May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs)
Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable

Senior Medical Director Resume Examples & Samples

Safety Surveillance and Rick Identification and Assessment Risk Management - Apply current regulatory guidance for risk minimization to AbbVie’s product safety, RMP/REMS plans, as appropriate
Knowledge of clinical AE profile ranges from familiarity with individual case safety reports for assigned products to comprehension of aggregate safety data across clinical trials
Ability to collaborate with internal and external relevant parties and develop a comprehensive risk management strategy for each of these topics
Spearhead efforts at the clinical team/PST level to further characterize and describe safety issues or potential safety concerns prior to NDA filing and foresee and help initiate post marketing opportunities for risk mitigation
Ability to interact externally and internally to support a global business strategy

Senior Medical Director Resume Examples & Samples

Prioritizing people development by establishing development opportunities for team members through implementation of development plans, training opportunities and relevant on the job challenges
Develop effective team communication, analysis and documentation of performance of medical affairs activities and knowledge through the application of appropriate governance, reporting systems and structures
Experience leading Medical Affairs function
Excellent communication skills both written and verbal
Ability to lead and motivate a team, both internally and remotely
Previous Clinical Operations experience (design and implementation of clinical trials)

Senior Medical Director, Clinical Development Resume Examples & Samples

To support the strategic design, execution, and interpretation of key clinical studies, with a special focus on Alzheimer’s Disease, which support high-priority Corporate initiatives
To lead a clinical program team to the eventual worldwide commercialization of approved agents
To contribute to growth of the pipeline through identification and diligence of in-licensing opportunities
To interact with multiple levels of management within Biogen as well with regulatory authorities
Provide strategic leadership for assigned clinical programs
Actively survey scientific landscape in biology and clinical science; identify external opportunities for in-licensing and support clinical and scientific diligence
Five or more years of experience in clinical or laboratory research
Industry experience, particularly in development within Neurology, is required
The ability to understand, analyze, compile, and present analyses of data
Strong organizational skills, both written and verbal
Ability to work cross-functionally to represent Clinical Development on project teams, committees and external meetings
Ability to work in a multi-disciplinary team setting and employ a team approach to decision making
Proven ability to work collaboratively with colleagues to direct global life cycle management
Ideally, have formed peer level relationships with therapeutic area opinion leaders worldwide
Familiarity with discussion of the science or mechanisms of new research approaches, clinical endpoints, protocol design, or data interpretation
Be a driven and innovative builder who has placed significant strategic bets in the therapeutic area and implemented those well
Strategic and critical thinking
Leadership and team-building skills, including strong problem solving, conflict resolution, and analytical skills
Experience leading clinical development teams

Senior Medical Director, Clinical Sciences Resume Examples & Samples

This position reports directly to the Vice President Clinical Sciences, Bio Marin Pharmaceutical Inc
The candidate is responsible for interpreting and evaluating results of research and making recommendations
She/He is responsible to see that the design and conduct of studies under her/his management are carried out with the highest medical and ethical standards with national government regulations including the U.S. FDA
Maintenance of expert scientific and medical knowledge is achieved, among other means, by attendance and participation at medical meetings and seminars and review of pertinent current medical and scientific literature

Senior Medical Director, Clinical R & D Resume Examples & Samples

Collaborate extensively with Business Development, Senior R&D and Commercial leadership to identify, recommend and develop strategic alliances, partnership and licensing opportunities requiring due diligence work and strategic input
Serve as a global lead for one or more functions such as: Clinical Science, Clinical Quality, Disease Area, Product Champion, Region CRD Development and Business Development
The ability to think globally, strategically and innovatively about the future of the disease state and company’s therapeutic agents and possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business, including Marketing and Sales, Market Access, Pricing/Reimbursement, Business Development, Medical Affairs and Supply Chain
Build teams by understanding the skills and capabilities needed to effectively meet goals and objections and align them with the talents and capabilities of team members
Optimize extensive knowledge of the clinical development process and strong relationships with team members, colleagues and internal and external stakeholders to achieve results
Foster innovation and informed risk taking among staff members and study team colleagues
Garner support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change

Senior Medical Director, Clinical R&D Resume Examples & Samples

Provide therapy area medical and scientific expertise to study teams and key stakeholders
Oversee quality, coordination and timeless of clinical sections of IND’s, Investigator Brochures, CTA’s, ISS’, ISE’s and clinical expert reports
Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL’s
Create complex strategies to develop the franchise or product and successfully articulate this to various constituents such as governance committees, project teams, clinical sub-teams, and other senior management to build enthusiasm, passion and commitment

Senior Medical Director, Neurology Resume Examples & Samples

Demonstrated familiarity with the entire commercialization process and with the broader marketplace dynamics to partner with commercial and product development leaders in lifecycle planning
Ability to take multiple therapeutic areas into account when assessing clinical value and adopt an independent view when analyzing risk versus benefit
Through scientific interactions (e.g., interactions with thought leaders and participation in congresses), gain valuable insight into treatment patterns, testing patterns and scientific activities and provide input to the company Medical Affairs Plan / business decision-making

Senior Medical Director, Ophthalmology Resume Examples & Samples

Demonstrated track record of successfully developing and executing Medical Plans (e.g., leading appropriate pre-launch, launch and post-launch medical/scientific activities)
Translates insights into actionable recommendations for cross-functional team members
Must be able to work effectively in matrix organizations by collaborating with cross-functional leaders and driving change without the reporting structure to impose it
Promotional review committee experience

Senior Medical Director Resume Examples & Samples

Provide medical and scientific expertise in analyzing, assessing and interpreting clinical studies and data as well as additional external medical and scientific information
Ability to act as an advocate for Medical Affairs with fellow leaders inside the company and be adept at maintaining contact with an expanding array of external stakeholders through multiple channels including conferences and social media
Develops and maintains relationships with key stakeholders, as well as thought leaders, advocacy and disease organizations/cooperative groups and professional societies
Experience successfully leading a matrix team with clinical study responsibilities
Ability to quickly and comprehensively learn about new subject areas and environments and effectively communicate that information

Senior Medical Director Resume Examples & Samples

PhD in epidemiology or MD/MPH or MD/PhD in epidemiology with minimum of 5 years applied epidemiology experience
Minimum of 5 years applied pharmacoepidemiology experience
Minimum of 3 years in Drug Safety, Clinical Safety, Pharmacovigilance or Risk Management preferred
Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally

Senior Medical Director, Clinical Development Resume Examples & Samples

Establish and drive teams to execute the strategic long-term vision for a key pipeline drug candidate
Contribute to the strategic development of other early and late stage clinical programs
Serve as a competent medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates

Senior Medical Director Resume Examples & Samples

Develop medical strategy, design and implement key initiatives which would align with the objectives of TR, and leads MA sub-functional therapeutic leaders during planning process to design respective plans in alignment with the medical strategy
Lead the annual Medical Planning process, designs Phase IIIb and IV clinical studies and serves as their Clinical Lead during the implementation, in cooperation with R&D, GCO, CROs, HEOR and Global Medical Affairs personnel at Teva, including interface with clinical investigators and vendors as appropriate
Participates in the clinical proposal decision processes, including review ofproposals and protocols of studies, supporting R&D, operational and HEOR teams
Leads scientific and medical reviews and go – no go decisions for Respiratory Disease and Allergy-Immunology products within the Investigator Sponsored Studies program
Serves as a “go to” functional liaison within cross-functional business teams and brand team developing overall business strategy for the brands of TR
Serves as an internal medical/scientific resource to Respiratory US Field MA (MSL team), Scientific Communications and Publication teams, HEOR, Regulatory Affairs, Business Development, Training, Copy Approval, Project Teams, IR&D and Commercial functions within TR
Oversees and manages projects with medical and scientific personnel and systems, provides organizationally aligned medical and scientific services, serves as the medical and scientific resource for all inquiries requesting a Medical Director opinion
Drives strategically aligned agenda and content development and leads Medical Advisory Boards for the respective TR products
Ensures medical and scientific accuracy in publication planning process, including review of abstracts, posters, manuscripts for publication and scientific symposia presentations
Builds advocate relationships and partnerships with key opinion leaders, scientific experts and centers of academic excellence in the NAMA Respiratory external expert community
Participates in budgetary processes as part of business planning and periodically tracks and manages expenses within his/her operating plan
Assists with development of SOPs for the activities conducted by Medical Affairs
Serves as the brand team Medical Affairs representative on US product brand teams within TR
Provides direct supervision to 2 Medical Directors within NAMA Respiratory
Leads NAMA Respiratory Team, interface with core functional global counterparts and relevant stakeholders and teams, as needed

Senior Medical Director Resume Examples & Samples

Oversee the denials and appeals department
May manage other medical directors
Assume VPMA responsibility in the absence of VPMA
Provide medical leadership for all utilization management, pharmacy, case management, disease management, cost containment, and medical quality improvement activities. Perform medical review activities pertaining to utilization review, quality assurance, and medical review of complex, controversial, or experimental medical services. Support the effective implementation of performance improvement initiatives for capitated providers
Assist VPMA in planning and establishing goals and policies to improve quality and cost-effectiveness of care and service for members. Provide medical expertise in the operation of approved quality improvement and utilization management programs in accordance with regulatory, state, corporate, and accreditation requirements
Assist the VPMA in the functioning of the physician committees including committee structure, processes, and membership. Oversee the activities of physician advisors and other medical directors. Utilize the services of medical and pharmacy consultants for reviewing complex cases and medical necessity appeals. Participate in provider network development and new market expansion as appropriate. Participate in provider profiling initiatives. Assist in the development and implementation of physician education with respect to clinical issues and policies
Identify utilization review studies and evaluates adverse trends in utilization of medical services, unusual provider practice patterns, and adequacy of benefit/payment components. Identify clinical quality improvement studies to assist in reducing unwarranted variation in clinical practice by profiling providers in order to improve the quality and cost of care. Interface with physicians and other providers in order to facilitate implementation of recommendations to providers that would improve utilization and health care quality. Review claims involving complex, controversial, or unusual or new services in order to determine medical necessity and appropriate payment
Develop alliances with the provider community through the development and implementation of the medical management programs. As needed, may represent the business unit before various publics both locally and nationally on medical philosophy, policies, and related issues. Represent the business unit at appropriate state committees and other ad hoc committees
Oversee all aspects of the Appeals and Denials department including implementing budgetary, policy, and personnel decisions for the department

Senior Medical Director, Multiple Sclerosis Resume Examples & Samples

Drive strategy and tactics supporting successful product development and commercialization within the Multiple Sclerosis portfolio
Lead MS global medical portfolio strategy
Drive organizational collaboration to ensure well developed and executed life-cycle management strategic plan; Drive consistency of Global Medical functional area and Regional/Affiliate strategies with GM and LCM strategy
Lead effort to provide worldwide medical input (representing all medical functions and regions) on the Program Teams to ensure successful registrational and post-marketing clinical trial design, provide medical field perspective, appropriate competitive intelligence
Drive communication and collaboration amongst Global Medical functions (globally, regionally and locally), and between Global Medical and other teams in R&D, Global Commercial, Market Access, Compliance and Legal
Lead Global Medical Multiple Sclerosis TA partnership with any partner company related to key functional activities
Lead departmental initiatives, both internally and externally, as the top technical expert in translating clinical data, insights and marketplace issues

Senior Medical Director, Infectious Disease Resume Examples & Samples

Accountable and responsible for leading and directing the creation of effective delivery strategies and solutions for large, complex, multi-service, multi-region studies or programs to include mega studies and portfolio management, addressing the specific needs and challenges of each customer and differentiate Quintiles from its competitors. In partnership with Sales, Medical, Operations and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets. Actively support long term enterprise business growth through collaboration with therapeutic Centers of Excellence and other stakeholders
Serves as Customer contact at senior levels
Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff
Maintains awareness of industry developments and participates in professional meetings, and may author related publications
Performs special projects as requested by management
Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study
Participates in the development of client proposals including the budgeting process
Will participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Therapeutic Science and Strategy
Budget responsibility for select projects; responsible for select projects and responsible for all project safety issues on assigned trials
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
Ability to establish and maintain effective working relationships with a wide network of individuals, e.g. co-workers, managers and customers
Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization
Innovative and strategic thinker
Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments
Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required
Confident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic knowledge and competitive landscape
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines

Senior Medical Director Oncology Resume Examples & Samples

Critical evaluation of potential strategic innovation proposals including molecular based strategies for future drug development, with a strong emphasis on clinical and scientific aspects
Lead cross-functional teams in design and implementation of innovative strategies for oncology drug development with patient population identified by molecular characterization and novel endpoints
Lead cross-functional team in drafting clinical development plans
Identify steps needed to generate relevant data supporting clinical development plans. This could be pre-clinical experiments or clinical studies
Drive the identification and delivery of the best collaborative opportunities with the various Roche functions (including the Roche Product Development Strategic Innovation team) as well as external opportunities with academic groups, non-profit research organizations, venture, biotech and big-pharma companies
Develop and maintain a strong collaboration structure custom-made to the particular collaboration (e.g., Lifecycle Teams)
Best represent Roche’s scientific excellence and high ethical standards when interacting with potential outside partners
Serve as a role model within Roche in developing a vibrant, entrepreneurial, environment supporting courageous leadership, innovation and collaboration
Promote a culture of scientific innovation and continuous improvement
Provide clinical guidance, where appropriate, in therapeutic areas other than that in established product development teams
Provide technical leadership for novel indications for portfolio assets at all stages of development
May manage teams in the delivery of program or collaboration objectives

Senior Medical Director Resume Examples & Samples

Play an important role in the development of medical strategy and execution of the Medical Plan for a major therapy
Manage / co-ordinate complex affiliate training
Act as a global contact to Affiliate / Regional Medical Affairs and other internal functions
Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic area (via publications, key meetings, interaction with key TAEs, as well as continuous communication and effective partnering with global functions and affiliates)
Undertake medical / scientific responsibility for assigned clinical studies and other sources of evidence generation (e.g. RWD ), including but not limited to defining study concepts / synopses, protocol development, medical monitoring, final study reports and preparation of data for publication of study results

Senior Medical Director Resume Examples & Samples

Develop and be accountable for the medical strategy for assigned molecules
Work within the matrix organization and ultimately be accountable for all medical affairs deliverables for assigned molecules
Serve as the in-house medical and scientific expert for molecules within the CNS therapeutic area and represent US medical affairs on various governance committees as appropriate
Interact internally with and support colleagues from Alliance Management, Business Development, Government Affairs, Managed Markets, R&D, Marketing and Sales
Develop and maintain relationships with key external experts through Professional Associations, Professional Meetings and Conferences, etc. in support of common scientific objectives
Manage the budget for the specific Cost Center and provide direction and oversight for the US MA overall therapeutic area budget
Either directly, or indirectly through supervision, oversee the medical review and sign off of promotional pieces in support of the Medical-Regulatory-Legal committee for products within your therapeutic area(s)
Participate in the publications strategy for assigned compounds by providing scientific and publication planning input, including review and sign off of materials for medical/scientific presentations and publications
Interact internally with senior level management requiring negotiation to guide the overall activities of the specific compound and therapeutic area
Develop and maintain relationships externally through Professional Associations and Meetings to achieve Takeda’s scientific objectives
Participate in external alliances and partnership in order to further Takeda's scientific objectives
MD degree with current or recent board certification in internal medicine and/or psychiatry and/or neurology
Prior experience in Medical Affairs
Experience in behavioral therapy (CBT) and psychologic or chronic medical disease

Senior Medical Director, Oncology & Genetics Resume Examples & Samples

Clinical medicine
Practice experience
Masters of Business Administration, Health Services Administration or Public Health
Professional society leadership

Senior Medical Director Clinical Coverage Review Resume Examples & Samples

Active license required
Board Certified in ABMS specialty required
Ability to focus on key metrics and continuously monitor performance for improvement
Ability to identify, analyze, and interpret trends or patterns in complex data sets
Locate and define new process improvement opportunities
Excellent program and project management skills
Proficiency in working in a matrix environment

M.d. / Ph.d Senior Medical Director Resume Examples & Samples

Responsible for the Clinical Pharmacology deliverables for the assigned projects
Responsible for appropriate clinical pharmacology input on project teams
Responsible for ensuring planning and direction of clinical pharmacology components on the clinical development plan
Responsible for high quality clinical input into the Clinical Pharmacology section of regulatory documents and registration dossiers
Responsible for providing strategic direction in clinical pharmacology studies and oversight for preparation of clinical pharmacology protocols, timeline, budgets, and study reports
Participate in abstract presentations and contribute in writing and/or reviewing manuscripts for publication
Responsible for the medical writing of clinical protocols
Oversees the development and implementation of Vanda QA program

Senior Medical Director Resume Examples & Samples

Responsible for subject-safety and the scientific integrity of clinical trials
Performs the duties of a Medical Monitor
Provides 24-hour coverage for clinical trials
Provides project-specific and therapeutic training to sponsors and Company staff as needed
Works with Medical Writing/Regulatory in the preparation of a variety of documents as required
Maintains in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines
Interacts with senior management, project management and other departments as appropriate
Provides clinical development and regulatory consulting advice both within Company and to clients as requested
Locates and interacts with outside experts as necessary
Provides feedback to management on quality issues within the clinical trial team

Regional Senior Medical Director Resume Examples & Samples

The Senior Regional Director ensures that all medical affairs involvement and activities are executed in full compliance with Vertex policies, local laws and regulations and codes of practice
This high profile leadership role requires a high level of understanding of the business and comprehensive technical and functional skills
A core part of the role is to ensure that medical documentation and clinical educational activities, including materials for payers, are of a high scientific quality, aligned with the European strategy and coordinated to meet country and corporate objectives
Managerial responsibility for country medical directors and associate medical directors
Responsibility for local financial planning and budgetary adherence of medical affairs activities, within the International Medical Affairs budget
As a local Therapeutic Area(s) and Vertex drug expert, is responsible for developing and maintaining professional relationships with Regional Health Care Professionals, and through their MDs with local Professional Societies and Patient Advocacy groups
Establishing relationships with External Experts to expand research opportunities for Vertex and develop, at local level, advisory, collaborative and/ or educational activities aligned to the Vertex strategy
Establishing and ensuring execution of a Medical Operational Plan, aligned with the International Medical Affairs strategy and local Brand plans, and in accordance with corporate policies and procedures and applicable local laws, regulations and code of practice
Ensuring that the scientific data provided locally to Health Care Professionals and Health Care Authorities is provided with a fair and balanced view. Acting as the local medical contributor and reviewer/approver of Field Medical Material (proactive and reactive), Promotional Material and Access Material for local use
Maintaining a seamless flow of information within and between the local structure and the European HQ, and communicating medical insights obtained locally from appropriate field interactions to inform local and regional strategy/ tactics
Experience in Medical Affairs within the biotechnology or pharmaceutical industry, preferably in a medical advisory role
Knowledge of national healthcare and regulatory environments indispensable, previous interactions with MHRA and/or payer bodies a distinct advantage
Excellent understanding of the reimbursement mechanisms in the UK and of the acceptability of PE models and PRO research by national payers
Knowledge and understanding of marketplace dynamics
Track-record of ability to plan, initiate and complete projects within allotted timelines and budget & delivering high quality successful results
Ability to work within a multi-disciplinary and multi-cultural team on common projects and goals, at national and regional level
Capacity to critically analyse current scientific literature
Good understanding of the basics of health economics and patient outcomes
Skilled in effective presentations of clinical/scientific data in a group or individual setting, internally and externally
Well-developed communication skills, with fluent written and spoken English

Senior Medical Director Resume Examples & Samples

Provide a clinical leadership interface with OptumCare/Local Care Delivery on expanding business partnerships, etc
Provide an oversight and decision making role in the development of new clinical and population health services for local physician practices; primarily OptumCare in 2016
Use an innovative approach to solve some of the most pervasive cost and quality challenges physician practices currently face in delivering high quality, affordable care
Actively participate in the development of new provider tools
Build a deep understanding of the existing solutions offered by CSG today so as to inform future development to improve the products and capabilities
Ensure solutions are rolled out and implemented in local practices to ensure they meet clinical design specifications and customer expectations
Help create operational efficiencies in how we engage and work with providers
Support the business in identifying key market trends that should influence key investments (i.e., technology investments and/or M&A)
Remain current with FDA and regulatory guidance as it relates to devices and digital care coordination engagement, oversee clinical quality review, and participate in regulatory authority meetings as required
Expand further on the delivery of OptumHealth Education content into the provider community
Current and non-restricted licensed physician; board certification in primary care specialty preferred
7+ years of clinical practice experience after completing residency training
5+ years in managed care industry with strong knowledge of provider risk and accountable care organizations
3+ years of experience in clinical information analysis role (analysis of data, identification of changes, creation of action steps based upon findings)
Familiarity with commercial and government markets and experience setting clinical policy for the wellness, case management, disease management and specialized networks
Demonstrated accomplishments in the areas of medical care delivery systems, utilization management, quality management, and peer review
Business background/experience in addition to a clinical background is a key attribute for success in this role
Experience in client-facing customer relationship management
Experience with leading, motivating and managing a team
Strong operational focus with demonstrated data analysis / interpretation acumen, project management, change management, and execution skills
Past success working collaboratively in a highly-matrixed environment
Ability to navigate ambiguity and seek appropriate resources / tools
Self-motivated and able to work with little direct supervision and drive results with disciplined follow-though
Strong strategic thinking and business acumen with the ability to align clinical related strategies and recommendations with business objectives
Adaptable and flexible style of collaborating with key stakeholders in setting direction
Proven ability to quickly gain credibility, influence and partner with employees, business leaders and the clinical community
High integrity with a reputation of a trusted confidential advisor and partner
Strong belief in EBM (Evidence Based Medicine), and familiarity with current medical issues and practices

Senior Medical Director Resume Examples & Samples

Collaborate with Commercial and Medical Affairs to develop a strong group of Key Opinion Leaders
MD degree required with Oncology sub specialty board certification preferred
Minimum of (4+) years of clinical research experience with a strong history of early development (post IND) drug development in oncology within biotechnology, biopharmaceutical, and/or pharmaceutical companies within a similar role
Some prior experience with biological therapies required
Broad understanding of oncology, internal medicine and clinical pharmacology
Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development, developed through success in gaining approvals
Knowledge and expertise in post-marketing pharmacovigilance, including the receipt and processing of post-marketing ADRs, completion of MedWatch forms, and generation of Periodic Safety Update Reports is preferred
Demonstrated experience and expertise in the primary authorship of multiple clinical trial protocols and clinical study reports, including oversight of the generation of tables, figures and listings from the study database

Senior Medical Director Resume Examples & Samples

Understand (and eventually develop into local expert for) the underlying scientific principles of the disease indications and pipeline molecules be studied
Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy and IND enabling studies, to develop optimal translational medicine approaches to facilitate development to clinical POC
Contribute to the development of a robust disease indication strategy aligned with the core focus and expertise of Alexion, based in disease pathophysiology and scientific mechanism of action of the molecules
Participate in the development of a scientifically rigorous early Clinical Development Plan; contribute to Biomarker Strategy and program Integrated Development Plan for each candidate compound, grounded in translational medicine approaches that mitigate risk and ensure and validate the mechanism of action, safety, and or development plan for each molecule
Act as medical and clinical expert on early stage project development teams. Act as team representative and internal champion to senior management and development review committees
Review (and contribute to the writing, where necessary, of) clinical protocol synopses and protocols, investigator brochures, and other documents as needed for regulatory and clinical operations activities
Serve as the medical monitor and, in conjunction with pharmacovigilance, the safety medical reviewer, on early stage (Phase 1 and Phase 2 to POC) clinical studies
Work closely with biometrics and clinical operations to ensure clinical operations and development program success
Foster and maintain strong relationships with external key opinion leaders (KOLs) in a peer-to-peer manner; act as internal Alexion expert
Contribute to the development of regulatory strategy and represent Alexion as the medical expert in meetings with regulatory authorities
Ensure effective leadership and governance within Translational Medicine, and seamless collaboration across all areas of Translational Medicine, including Discovery Research, Early Development and Clinical Development functions
Work with project leaders and line function management to ensure effective team management of programs and to ensure smooth and efficient transition of compounds to late stage development
Coach and develop colleagues in best practice and help develop skills and expertise
A minimum of 5-8 years of experience in both preclinical and early clinical development or clinical translational medicine experience within the pharmaceutical or biotech industry. Experience in ultra-orphan disease a plus
Experience in the development of biologics, and knowledge of regulatory activities in US and EU, as well as direct experience with IND filing required; additional experience with NDA filing helpful
Strong scientific research background in clinical therapeutic area; Additional PhD or specific expertise in rare orphan diseases helpful
Fluent English, excellent written and verbal communication skills with successful presentation capabilities required
Experience building and leading a team of direct reports
Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals
Ability to travel on average 20% of the time (range 0-30% each month)

Senior Medical Director Atopic Dermatitis Dupilumab Resume Examples & Samples

Lead the development of an Integrated Medical Plan (MSLs, IME, Medical Communications and Publications, Health outcomes, Safety and Clinical Research (phase IIIB-IV and ISTs)) and annual budget for assigned brand(s)
Lead and monitor the execution of the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables
Communicate the details and progress of the Medical Plan to Senior Management, the Core Team and all parties responsible for execution
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s)/projects
Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development
Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations
Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR)
Review, approve and supervise all aspects of US phase 111B - IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines and the accurate and timely reporting of study data
Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH)
Lead the review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s)
Identify and communicate Product Alerts to the Core Team (in conjunction with U.S. Drug Safety, USRAMP, GMA)
Partner with U.S. Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals
Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within pertinent medical community
Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development (in conjunction with RML)
Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc
8-10 years. Relevant experience in Medical Affairs
MD/DO preferred. Doctorate (PhD., Pharm. D. or advanced degree) with relevant experience

Senior Medical Director Resume Examples & Samples

Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues
Has overall responsibility for leading clinical study teams, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned
Primary responsibility for and ownership of design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents
May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs) and/or other cross-functional teams and internal stakeholders
Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in Oncology
Completion of a residency program strongly preferred. Completion of a Oncology / Hematology fellowship is desirable
At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols

Senior Medical Director Resume Examples & Samples

Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and AbbVie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs
Completion of a residency program strongly preferred
Completion of a Oncology fellowship is desirable

Senior Medical Director Resume Examples & Samples

Act as the US/international clinical lead for the compound to both internally and externally facing stakeholders by providing high-level input
Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems independently
Ensure compliance with Vertex SOPs, ICH, GCP and other national and international regulatory requirements
Minimum of 5 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s) Neurology training and/or industry background
Board certification/eligibility in a specialty area
Ability to work collaboratively in a challenging team matrix environment
Have a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes
Experience in filing and defending US INDs and/or NDAs

Senior Medical Director Resume Examples & Samples

Collaborate extensively with Business Development, Senior R&D and Commercial leadership to identify, recommend and develop strategic alliances, partnership and licensing opportunities requiring due diligence work and
Reinforce open-mindedness, diversity of thought, collaboration, best practice sharing and risk taking among team members and stakeholder groups
Make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior management

Senior Medical Director of Oncology Resume Examples & Samples

Functions as project team member
Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus
Excellent oral and written communications skills as well as interpersonal skills are essential
Ability to travel domestically and internationally as required

Senior Medical Director Resume Examples & Samples

MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions
Diplomacy and positive influencing abilities

Senior Medical Director, Psychiatry Resume Examples & Samples

MD, Board Certified Psychiatrist, or internationally recognized equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Development experience beyond US/EU a plus
NDA/MAA/Submission experience preferred
Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
Regional/global Regulatory requirements
GCP/ICH

Senior Medical Director, VBD Resume Examples & Samples

5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned)
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required
Requires approximately 15 - 25% travel
LI-TC2-EUR

Senior Medical Director Resume Examples & Samples

Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty (Multiple Sclerosis)
In an academic or hospital environment
Completion of a sub-specialty fellowship is desirable
Minimum of 5 years experience working in Multiple Sclerosis

Senior Medical Director Resume Examples & Samples

Chairs the Corporate Quality Improvement Committee: the Quality governing body for Cigna-HealthSpring Medicare, Medicaid and MMP Quality programs
This committee ensures alignment with CMS Quality Improvement Program requirements
Participates in the development, implementation, and monitoring of Quality Improvement Project and Chronic Care Improvement Programs
Chairs other Health Services committees as required
Understands applicable CMS regulations and requirements impacting Quality Improvement and ensures appropriate application of same with Enterprise and market activities and policies
Chairs the National Physician Advisory Committee and oversees Quality of Care case leveling, performs regular audits of QOC cases to ensure inter-rater reliability
Chairs the Clinical Guidelines committee and performs an annual review of the clinical guidelines to ensure they are up to date with current evidence based guidelines
Evaluates available data sources to assess the quality of medical care provided to members all health plans and directs the development of interventions to address identified opportunities to improve the quality of care for all HealthSpring members
Assist Leader for NCQA activity contained within the company plans in the development, implementation, and maintenance of medical management projects
Participates in benefit designs and levels based on quality analysis and outcomes
Oversees various sub-committees reporting to the CQIC including clinical guidelines, coverage determination, delegation oversight, credentialing, policy development and others
Leads the quality aspects of the Partnership for Quality (P4Q) program designed to engage the provider network in quality improvement around various quality metrics
Serves as liaison with government programs division to prospectively understand and represent the company to CMS and influence where possible upcoming regulations, requirements
Responds and manages CMS audits related to medical management
Prepares and delivers presentations to providers, accrediting organizations, and regulatory bodies regarding the plan, its quality program and outcomes
Works collaboratively with Enterprise Operations Departments (e.g., Credentialing, Delegation Oversight, Customer Service…) to achieved project outcomes and clinical strategy deliverables
Serves on leadership committees with Enterprise compliance, Delegation oversight
Reports on the effectiveness of the QI to the senior leadership team, operational team and Board of Directors
Collaborates on HEDIS related activities and assists in developing assessments and interventions for overall improvement in HEDIS scores
Collaborates with Cigna Commercial Quality Chair in further integrating and coordinating implementation of best practices within both entities
Supports STARs activity within the Enterprise and markets
Participates in the selection of and retention of providers and quality personnel
Participates as required in national organizations such as AHIP representing Cigna-Healthspring
Provides support and guidance for the Enterprise Appeals Unit
Collaborates with other Cigna-HealthSpring divisions as necessary for managing all applicable Medicare & Medicaid requirements
Active and unrestricted Medical License and current Board Certification
At least five years of hands-on patient management in licensed discipline
At least three to five years of clinical experience in a managed care organization particularly in quality activities
Good project management skills

Senior Medical Director Resume Examples & Samples

Supports growth and persistency through strategic collaboration with Market Leaders, Sales, and Account Management to achieve Market & Segment Sales goals
Acts as the clinical expert within the market and uses analytics coupled with clinical expertise to maximize growth with our clients
Responsible for the achievement of superior clinical quality and market goals for total medical cost competitiveness, medical utilization trend and clinical integrity as well growth targets including, but not limited to, earnings and expense management
Drives market growth and account retention within the Regional Segment, including specialty results and penetration, by serving as the key clinical expert with customers and producers within the assigned market
Serves as market clinical representative in provider community, drives provider feedback back into the organization and insures clinical quality and integrity achieve high standards
Collaborates with providers and delivery systems to instill pay-for-performance discipline and quality
Fosters and enhances Cigna's Value Based Reimbursement strategy in the market through Cigna Collaborative Care (ACO) arrangements, Specialty Care Collaboratives, and Hospital Care Collaboration
Acts as quality and statutory medical director for the market; is viewed as credible clinical leader within the market by both internal and external partners
Owns the market from a clinical perspective
Develops and leverages strong partnerships both externally with individual vendors, providers and c-suite relationships within major facilities and internally with matrix partners in sales, underwriting, clinical operations, medical economics, network, informatics and product to achieve market targets
Builds and maintains strong interconnectivity with the Clinical Operations organization to ensure consistent clinical and network approach and related execution are maximized
Actively engages the Clinical Operations teams (physicians, nursing and allied health) on impact and trends of clinical operations within the specific market
Provides solutions for improvement while assuring appropriate balance between clinical quality and impact on medical costs, operational efficiency, and service to internal and external customers and providers
Direct contributor to medical action planning and strategy development and implementation for network management and regional sales and account management
Diagnoses market specific total medical cost improvement opportunities and designs and implements interventions and solutions
Collaborates with market contracting and provider relations teams to optimize network performance for quality and appropriate utilization
Supports market provider contracting staff with clinical expertise for the development and execution of contracting initiatives and negotiation of rates
Develops and maintains the market’s clinical program’s strategic direction, assesses new opportunities, and leads a cross functional team to implement and/or improve programs
Translates strategies into tactical delivery plans and monitors the execution of these plans to drive/maximize results for customers and shareholders
Participates, where possible, in special projects as the Market Facing Clinical expert to develop strategic solutions and actions focused on key business initiatives
Active and unrestricted Medical License in Illinois preferred
Current Board Certification; primary care preferred
Minimum 5 years of clinical practice experience
At least 3 year’s experience in a business environment
Proven ability to function in a heavily matrixed environment
Ability to foster collaboration, value others perspectives and gain support and buy-in for organizational proposals
Ability to drive results, think strategically and implement tactically
Strong relationship building and influencing skills
Strong organizational and execution skills
Ability to convey complex information in an understandable way to various audiences
Strong analytical skills and problem solving skills
Demonstrated ability to effectively prioritize and manage multiple priorities simultaneously

Senior Medical Director Resume Examples & Samples

Develop and execute medical plan, design and implement key initiatives which would align with the objectives of CNS, and leads MA sub-functional therapeutic leaders during planning process to design respective plans in alignment with the global medical strategy and plan
Lead the annual US Medical Planning process, designs Phase IIIb and IV clinical studies and serves as their Clinical Lead during the implementation, in cooperation with R&D, GCO, CROs, HEOR and Global Medical Affairs personnel at Teva, including interface with clinical investigators and vendors as appropriate
Serves as a “go to” functional liaison within cross-functional business teams and brand team developing overall business strategy
Serves as an internal medical/scientific resource to US Field MA (MSL team), Scientific Communications and Publication teams, HEOR, Regulatory Affairs, Business Development, Training, Copy Approval, Project Teams, IR&D and Commercial functions for all launch related activities
Provides internal Medical Education in alignment with Global Matrix education program and plan
Drives strategically aligned agenda and content development and leads US specific Medical Advisory Boards
Builds advocate relationships and partnerships with key opinion leaders, scientific experts and centers of academic excellence in the external expert community
Ensures US Medical Governance - TEV48125 launch related (e.g. Medical Information, IIS areas of interest coordination)
Member of Global Medical Fremanezumab Team and Global Medical Matrix Team Migraine & Headache and Pain
Serves as the brand team Medical Affairs representative on US product brand teams
Interface with core functional global counterparts and relevant stakeholders and teams, as needed

Senior Medical Director Resume Examples & Samples

Shape the US value proposition for Infectious Diseases products, both approved and in the pipeline
Lead the strategic development of clinical development plans with appropriate stakeholder
Partner with medical communications group to develop a publication strategy
Coach direct reports to create and implement development plan
Develop effective working relationships with physician leaders, regulators, internal and external partners
Collaborate with sales and marketing in the development of franchise objectives
An MD/DO degree with a specialty in Infectious Diseases and significant clinical experience is required
A minimum of 5 years of pharmaceutical experience is required
Infectious disease fellowship/training is required
Extensive HIV, Viral Hepatitis or ID respiratory disease experience is strongly preferred
Demonstrated performance in managing clinical programs is preferred
Expert knowledge of FDA regulations related to clinical research and drug development is required
Supervisory experience managing professionals in the pharmaceutical industry or related industry is preferred
Strong leadership capabilities are required
Will require up to 30% annual travel (domestic and international)Clinical Research MD

Senior Medical Director Resume Examples & Samples

Education/Experience: Medical Doctor or Doctor of Osteopathy, board certified in a primary care specialty (Internal Medicine, Family Practice, OB/GYN, Pediatrics or Emergency Medicine)
Course work in the areas of Health Administration, Health Financing, Insurance, and/or Personnel Management is preferred
Previous experience within a managed care organization and with Medicaid programs is preferred

Senior Medical Director Resume Examples & Samples

In-depth knowledge and experience in managed care / ACO’s and JV’s/ competitive environment
3-5 years of experience in Payor or Health Care Delivery System
Maintain a comprehensive working knowledge of community resources, payer requirements and network services for target population to maximize benefit to patient overall wellbeing
Understanding of local delivery model to inform and lead member medical management in collaboration with the ACO/JV Partner
Attend JV meetings as required
Local travel is required
Other responsibilities as required

Senior Medical Director Resume Examples & Samples

3+ years of Clinical experience
M.D. and/or D.O
Experience with Primary Care or Medicare Population Specialty
Experience with Medicare-risk programs
Experience with the management of IPA, PHO and/or Group Practice Models related to Medical Utilization and/or Resource Management and Quality Assurance
Solid Pre-Authorization, Utilization Review, and/or Quality Assurance background

Senior Medical Director Resume Examples & Samples

Provides clinical oversight across all relevant studies and programs
Leads and/or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communications
Designs and develops clinical studies
Contributes clinical science input into the relevant therapeutic/disease area scientific strategy. Helps research and other PD groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals
May consult on relevant acquisitions, joint ventures or other strategic partnerships
Participates in competitive intelligence and/or other market/industry assessment activities and projects
Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc

Senior Medical Director Resume Examples & Samples

Provides clinical leadership to the Plan's clinical staff including the development and interpretation of medical policy and technology assessment to assure the appropriate delivery and quality of health services
Analyzes and interprets trend data relative to utilization management and clinical programs to ensure processes are in place to meet and exceed organizational goals
In conjunction with the Plan's clinical staff develops and implements strategic plans specific to trends and changes in medical care and medical management, patient safety, and clinical quality; ensures that appropriate metrics are designed and implemented for comprehensive program(s) assessment. Monitors and ensures the achievement of desired outcomes
Responsible for the leadership and execution of the Plan's clinical quality activities and medical expense management in assuring the delivery of cost - effective and quality health care
Contributes to the development and execution of regional and Plan specific health care affordability initiatives
In collaboration with Corporate Clinical Quality staff, has local Plan oversight of Quality Plan activities inclusive of successful performance on key quality indicators such as STAR, HEDIS, and CAHPS
Accountable for the effective clinical engagement / relationships with key external stakeholders inclusive of: State and Federal government officials, industry related associations such as the Mississippi State Medical Association (MSMA), key health / medical and community based providers such as Skilled Nursing Facilities (SNF's), Federally Qualified Community Health Centers (FQHC's) Aging Service Access Points (ASAP's), primary care practitioners, hospitals and member population specific specialty societies such as the American Geriatric Society (AGS)
Responsible for oversight and direct management of employees and specialty consultants, 24 / 7 call program and of staff inclusive of Medical Directors to include completion of performance appraisals, annual salary planning, time and attendance management, overall employee satisfaction, etc
Unrestricted Medical Licensed Physician
Medical license in NY or eligibility to obtain
Ability to obtain multiple State Medical Licensures
Board Certified ABMS
Excellent interpersonal skills
Ability to develop and maintain effective relationships with key external stakeholders including government representatives, industry staff and the wide spectrum provider community (medical and community based) that serves the Plan's members
Strong knowledge of managed care industry
Ability to focus on key metrics
Familiarity with current medical issues and practices
Visibility and involvement in medical and local communities

Senior Medical Director Resume Examples & Samples

Must have an understanding of Pharmacovigilance practices for Clinical Development program
Ability to interact externally and internally to support global business strategies
Strong understanding of the pharmaceutical business
Must have an in-depth understanding of the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory

Senior Medical Director, Clinical Development Resume Examples & Samples

Contribute to the strategic development of early and late stage clinical product candidates
Serve as the joint development committee clinical lead for partnered development programs
Provide oversight and contribute to the development of clinical protocols and amendments, investigator brochures, and clinical study reports
Initially lead clinical study teams and provide appropriate medical monitoring for ongoing clinical studies, with the expectation of hiring and management of additional medical monitors to support clinical program needs with advanced development
Evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies
Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders
Is a team player, works well in a team environment both as a leader and a key contributor

Senior Medical Director Resume Examples & Samples

Participates in the development of CIT combination strategy for solid tumors
Interacts with a variety of external partners and stakeholders, such as clinical investigators, scientists and other key external experts (EEs)
Develops key clinical collaborations with biotechnology and pharmaceutical companies, as well as academic institutions
In collaboration with internal and external partners, participates in the design and implementation of CIT combination clinical studies
Participation on joint development committees with external clinical collaborations to provide scientific and clinical input and oversight across all relevant clinical studies
Reviews and presents key external clinical collaboration results to internal committees
Participates in relevant internal and external clinical meetings
Contributes clinical science input into other relevant therapeutic/disease area scientific strategies. Helps research and other PD groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals
Collaborates with cross-functional internal groups including PD, research, business development, commercial operations, legal, etc

Senior Medical Director Global Pv-gi Resume Examples & Samples

In conjunction with VP Global Medical Safety/Executive Medical Director, will lead and direct the interpretation of safety data from internal and external studies. To communicates at senior leadership level the impact of such data in terms of “go/no go” decisions or modification of development plans and/or study designs and the associated impact on timelines and/or labeling
Responsible for reviewing, analyzing and interpreting information from ongoing clinical and non-clinical studies alongside the assessment of ensuing scientific and medical implications and making recommendations based on new safety information for both developmental compounds and marketed drugs to ensure the primacy of patient safety
Viewed as the SME in PV Medical Safety for the assigned therapeutic area, mentors other PV physicians with respect to compounds in development and market drugs, safety monitoring and risk management assessment and analysis
Supports cross functional (within and outside Global PV) team evaluations in preparation for Takeda Safety Board presentations as well as having the leadership role for assigned products in safety data presentations to Safety Board
Oversees the medical safety evaluation of projects by the PV physicians for new business development opportunities (e.g., due diligence evaluations)
Directs PV interactions with Regulatory authorities
Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues
Manages PV physicians in the preparation, analysis and presentation of safety information
Medical degree required or internationally recognized equivalent
Direct clinical experience with patients following post-graduate training with appropriate grounding and knowledge of general medicine
Minimum 3 years people management experience and/or proven leadership experience in managing a global, matrix team
Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
Able to lead teleconferences and meetings
Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills

Senior Medical Director Medical Resume Examples & Samples

BC Pediatrics Residency Trained physician with BC in Pediatric sub-specialty
Knowledge and experience in leading and developing quality initiatives, improvements and programs to include, if necessary, appropriate metrics and benchmarks
Possessing high standards for excellence, the Director is relentless in the pursuit of a culture whereby outstanding clinical practice and customer service go hand in hand
Knowledge and practical mastery of clinical quality improvement methods and tools. Experience working with an integrated data warehouse with understanding of how to leverage clinical, operational, and financial data to motivate and direct improvement at the management and frontline levels
Experience leveraging the electronic health record for quality and safety improvement
A skilled communicator and a very visible presence, with strong interpersonal skills (written and verbal), able to build consensus among individuals and programs

Senior Medical Director Resume Examples & Samples

Lead the development of the Core Medical Plan for assigned products and accountable for execution
Support the creation and delivery of scientific and medical content for product level training internally and externally
Partners with HEOR lead to drive HEOR gap analysis, and ensure projects to address these gaps are reflected in the CMP and support the creation of the Core Value Dossiers and outer outputs needed to support Access
Provide support in coordinating medical activities at medical and scientific conferences
Contribute in discussions with Development colleagues and ensure that MA (including HEOR) perspectives are provided and incorporated in Development plans
Able to lead or co-lead projects within MA beyond their TA
Build and maintains relationships with global experts and able to obtain important key scientific insights to support the TA
Effectively lead matrix teams of global and functional colleagues; ensure effective cross-regional and cross-functional collaboration; align all key MA projects globally for assigned product and indication. Champion an objective and evidence-based solution oriented approach
Promote the Astellas Way
Medical Degree (MD). Holds an appropriate medical degree and certification recognized by one of the leading medical governing bodies from around the globe
At least 5 years total industy experience including country/region or global medical affairs, medical safety, or clinical development. At least 3 years Medical Affairs experience
Has good knowledge of TA/disease/product and is able to operate across several products within TA. Able to effectively communicate knowledge (TA/disease/product) to others
Experience in successfully leading cross-regional and cross-functional matrix teams either within Medical Affairs or clinical development. The ability to influence without direct authority is a critical skill set for this role
Demonstrates complex problem solving skills and ability to manage more comples problems within TA or product teams
Has full understanding of rules and regulations in pharma, including knowledge of global regulatory bodies and procedures, as well as anti-kickback laws, which could have impact for the pharmaceutical industry. Appropriate knowledge of guidelines and regulations such as IFPMA (International Federation of Pharmaceutical Manufacturers Association), PhRMA (Pharmaceutical Research and Manufacturers of America), FDA, EMA, PMDA, ACCME and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities
Fluent in written and verbal business English
Experience in managing large Medical Affairs budgets with demonstrated ability to apply pro-active risk management on budget and timelines

Senior Medical Director Resume Examples & Samples

Oversee scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function
Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors

Senior Medical Director, Clinical Development Resume Examples & Samples

Accountable for the development of the Clinical Development Plan/strategy for each asset reflective of the appropriate balance of risk, scientific rigor, and value to patients and share-holders, and cost. Achieves this both through direct action as well as through the supervision of junior MDs
Serves as primary interface with internal stake holders as well as external KOLS and Regulatory authorities for assigned programs
Accountable for production of highest quality clinical elements of study, program, and Regulatory documents including protocols, IBs, briefing documents, and drug labels
Accountable for attracting, retaining, developing and supervising 1-2 Associate / Medical Directors in drug development
Leads the technical evaluation of business development activities for stroke

Senior Medical Director Resume Examples & Samples

Responsible for direct management of projects and personnel within the department
Responsible for the development of an IST working plan for appropriate products or therapeutic areas
Responsible for providing medical input into development, execution and interpretation of Phase I, II, III and IV clinical protocols. This includes review of draft IST protocols, reports and manuscripts
Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations and preparing reports to the management and medical community
Act as a key member of the ISTRC and MPRC committees
Interact in collaborations with strategic partners
3+ years experience in pharmaceutical or biotech industries, Medical Affairs experience preferred
Intellectual strength, analytical ability and high professional standards in designing, conducting and evaluating clinical research
Outstanding leadership, team, presentation, written and oral skills required
20-40% travel requirement and may include weekends

Medical Director / Senior Medical Director Resume Examples & Samples

Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff
May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable
At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols

Senior Medical Director Resume Examples & Samples

Develop policies and procedures, and standard operating procedures that will provide a consistent approach to clinical appeal medical director adjudication processes for the clinical appeal departments across all three business segments
Directly manage appeal and grievances medical directors in his/her reporting structure
Interface with senior management across the three business segments
Maintain federal and state regulatory compliance for clinical appeals
Oversee escalated issues regarding specific appeal and grievances cases adjudications related to risk management and/or compliance issues
Participate in various audits for accreditation, compliance, and quality management
Perform individual case review for appeals and grievances for various health plan and insurance products, which may include PPO, ASO, HMO, MAPD, and PDP. The appeals are in response to adverse determinations for medical services related to benefit design and coverage and the application of clinical criteria of medical policies
Preparation and management of legal and risk cases with the potential for written responses, testimony in depositions and various forms of legal hearings
Peer to peer communications in investigating appeals and grievances related issues
Communicate feedback with UnitedHealthcare medical directors regarding appeals decision rationales, and benefit interpretations
Actively participate in team meetings focused on communication, feedback, problem solving, process improvement, staff training and evaluation, and the sharing of program results
Excellent presentation skills for both clinical and non clinical audiences. Familiarity with current medical issues and practices
Unrestricted medical licensed physician; Board Certified in a medical or surgical specialty/subspecialty
10 years clinical practice experience

Senior Medical Director Resume Examples & Samples

Translate insights into actionable recommendations for cross-functional team members
Develop and maintain relationships with key stakeholders as well as thought leaders, advocacy groups, and professional societies
Must be able to work effectively in matrix organizations by collaborating with cross-functional leaders and driving change
Has a leading role in oversight, review, analysis and approval of company sponsored and investigator-initiated clinical studies for the pharmaceutical products assigned to him/her including their execution
Plan and supervise early, late-stage, and post-approval clinical studies, acting as the intellectual driver behind a comprehensive scientific strategy for all trials aimed to integrate, expand and complement data from Science and Technology
Responsible for setting the agenda and leading advisory boards, investigator meetings, external medical strategy forums, and other key internal/external focus meetings as determined appropriate
Act as the company’s senior scientific consultant and as the therapeutic area expert to internal Mallinckrodt stakeholders such as the Commercial organization/Brand Teams, Science and Technology, other GMA teams, etc
Supervise preparation of product- and protocol-specific presentations to clinical trial sites, DSMBs, internal and external review committees, partners, and collaborators
Respond to questions and requests for information from regulatory authorities, ethics committees, and other review/oversight panels pertaining to Mallinckrodt’s portfolio
U.S. licensed Medical Doctor (MD) or internationally recognized equivalent with board certification or board eligibility strongly preferred
Advanced training in the field of burn/wound care research, regenerative medicine, or Dermatology
Strong background in clinical research and research management
Minimum 10 years’ experience within the company’s specific scientific discipline with the knowledge and expertise required within the fields of acute and chronic wound care; or equivalent experience in healthcare management with a minimum 3 years’ experience in relevant therapeutic area
Unique combination of research and clinical practice experience strongly preferred

Senior Medical Director Resume Examples & Samples

Leads medical management and quality initiatives for assigned area to include utilization management through a matrix partnership, Quality Improvement & accreditation initiatives, Pharmacy utilization, quality and cost management of provider network, and program leadership for various corporate and local initiatives designed to improve member care and minimize unnecessary costs
Interprets medical policy for associates to facilitate the healthcare needs of plan members
Works closely with P&L owners to develop strategies to change member and provider behavior to improve quality of care, while also reducing medical costs
Works closely with and influences key business partners within a matrix organization faced with competing priorities
Chairs medical policy, credentialing and related health plan committees
Works with the medical community to assist in the development and maintenance of a strong, quality network of providers
Supports provider relations and risk contracting through education, provider visits and problem resolution
Visits targeted providers for recruitment, as well as performing proactive provider visits as scheduled
Works with quality management and medical cost analysis staff to identify trends in treatment and outcomes by interpreting various data
Reviews provider and member complaints, assist in resolution, and make recommendations for changes
Utilizes clinical expertise to assist in the development of care improvement programs to improve health outcomes for the member population
7+ years of experience in direct patient care and a strong working knowledge of managed healthcare required
Substantial experience and expertise in the development of medical policies, procedures and programs is required
Qualifications to perform clinical oversight for the services provided by the health plan to include but not limited to: Education, training or professional experience in medical or clinical practice, is required
Past participation in hospital managed care or medical practice UM committee preferred
Demonstrated success implementing utilization tools/techniques and experience with physician behavior modification
Intermediate proficiency with Microsoft Outlook, Word, and Excel required

VP, Senior Medical Director Resume Examples & Samples

Improves the utilization of all medical services by contributing to the strategic direction for medical management programs including case management, prior authorization programs, disease management and pharmacy management
Participates in establishing clinical policies and communicates the application of clinical policy internally and externally as it pertains to processes such as claims, utilization management, quality management and pharmacy management
Supports case management activities as an integral member of the case management teams. Resolves case management questions and conflicts including interacting with attending physicians, physician advisors and IPA Medical Directors
Reviews appeals, grievances, and DOI level appeals.and makes determinations and/or recommendations regarding disposition. Participates and testifies at ALJ hearings on behalf of the company
Develops the skills and medical management capabilities of physician organizations and their medical directors. Cultivates cooperative relationships with their respective organizations through leadership of key provider partnerships, designed to improve the quality and cost-effectiveness of care delivered to members. May chair the Medical Directors Committee
Participates in the management of pharmacy programs. May act as a member of the Pharmacy and Therapeutic Committee
May, in consultation with other leaders in Health Services, develop, refine and apply credentialing policy in accordance with NCQA standards. Reviews all credentialing and re-credentialing applications for network providers and facilities, and makes recommendations to the QIC for those requiring further review
Chairs the company’s Quality Improvement Committee (QIC). Provides reports of the QIC to the Quality Management Committee (QMC)
Vice-Chair of the Quality Management Committee (QMC), to develop quality improvement policies and initiatives
Acts as the lead Health Services resource concerning Medicare-risk policies and programs as they relate to medical and quality management of a Medicare population
Serves as the medical director resource for the Prevention and Wellness department, including assisting with HEDIS/STARS data interpretation, participating in the Clinical Outcomes Group (COG), reviewing all new member prevention initiatives and correspondence, and serving as a member of the company’s Wellness Steering Committee
Licensed Physician (MD or DO)
Board certified in area of expertise
Primary care specialty or other Medicare population specialty desirable
Unrestricted license to practice medicine in CT and other states as appropriate/needed
At least 3 years clinical experience
Advanced degree desirable (MBA, MMM, MPH)
Experience with Medicare-risk programs required
Experience with the management of IPA, PHO and/or group practice models related to medical utilization, and/or resource management and quality assurance
Computer literacy (Microsoft Word, Excel, PowerPoint, and Access) desirable as it relates to the ability to manipulate and analyze data

Senior Medical Director for Oncology Resume Examples & Samples

Provides medical expert opinion, interpretation of clinical trials & research across different products in oncology area
Excellent understanding of the regulatory framework & requirements related to products, clinical studies and global drug development
Supports generation of publications and expert reports
Prepares medical assessment to support Business Development (BD)
Engages with external key opinion leaders in the area of oncology
Advise clients on a broad array of issues relating to pharmaceutical regulations and product development
Advise R&D on recent developments in risk management requirements
Establishes and approves scientific methods for hypothesis, rational, design of clinical protocols in oncology area
Ensuring company compliance with legal policies, laws and regulati
Provides benefit/risk evaluations and drug safety expertise for drugs, diagnostics, and devices in development and during market authorization
Able to present clinical data at major congresses
M.D. with 5 years or Ph.D. with minimum 7 years industry experience
Understanding of Medical Affairs activities
Understanding of marketing concepts/strategies
Knowledge of the pharmaceutical marketplace
FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area
Knowledge of regulatory guidance regarding marketing/sales promotional materials
Strong overall written and verbal communication skills
Must have requisite skills to function in a complex and dynamic environment, including flexibility and ability to negotiate

Senior Medical Director Resume Examples & Samples

Mentor team members and inspire department to higher strategic thinking
Management of direct reports
Contribute regularly to internal knowledge management efforts

Senior Medical Director, Pharmacovigilance Resume Examples & Samples

Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
Develop core knowledge of adverse events commonly associated with pharmaceutical agents- including long QT syndrome, hepatotoxicity, bone marrow toxicity, drug-drug interactions, nephrotoxicity and immunogenicity- and expertise in one of these topics. (Expertise demonstrable by ability to serve as internal consultant.)
Track known safety issues and potential safety concerns throughout the products’ lifecycle (Product Safety Plan)
Communicate new safety issues or potential safety concerns to PV management and PST as necessary

Senior Medical Director Resume Examples & Samples

Key contributor to the overall management, planning, evaluation and documentation of projects and studies
Leadership role in internal enrichment programs and publication strategy
Participation in on-going medicine development activities including
Analysis and interpretation of on-going studies and published data
Participation in the preparation of abstracts, posters, presentations for scientific meetings and congresses
Participation in publications based upon scientific data
Developing and writing clinical plans and protocols

Senior Medical Director Mltss Resume Examples & Samples

Provide clinical leadership and support for Quality Improvement programs, as well as meeting or exceeding all regulatory requirements. Serve as Clinical Leader for the UPMC For You program
Collaborate with CMO, Medicaid and Behavioral Services and engage all functional areas of MLTSS from a clinical perspective to develop innovative programs as well as products lines; serving as the primary clinical liaison with Network Services, Strategic and Advisory Services, Finance and Underwriting, Marketing, Operations, Information Systems, Pharmacy, and Product Development
As CHC and in particular UPMC expands its membership, motivate and mentor UPMC Health Plan's clinical and Medical Affairs staff by 'setting the pace' and fostering 'excellence by example'. Assess the overall team, including ongoing recruitment and hiring of talent. Ensure that the organization has the 'right people' in the 'right positions' and that the organization's structure is designed to maximize result
As a clinical 'thought leader' and CHC physician liaison, participate in the creation of opportunities to consult, interact and elicit feedback with the physician community, then act upon this valuable information, raising proactive clinical intervention to unprecedented levels
Collaborate with CMO, Medicaid and Behavioral Services and other Health Plan senior leadership in the development of short-term, mid-term, and long-range strategic planning for the Health Plan. Partner with physician leaders, and hospital and business executives to exceed clinical, operating, financial, quality, and market share objectives. Deliver executive level presentations for UPMC senior management and other designated groups
Collaborate with physicians to develop clinical programming by accessing and mining clinical data, devising methods to manage populations. Partner with physicians to improve reimbursement model and performance based physician incentive programs
Assist with the development of a clinical organization which prioritizes the retrieval and intuitive interpretation and evaluation of statistics and medical trends in order to establish aggressive preventative health targets and objectives
Ensure continuous improvement strategies are established and implemented for Health Management outcomes and processes, encouraging a culture which initiates intensive and persistent case management for members
Serve on physician committees and work with each Health Management program to monitor, assess and ensure the program's clinical success
As an integral member of UPMC Health Plan's leadership team, serve as a 'role model' and 'health advocate' within the Pennsylvania community, including active participation with UPMC sponsored activities, public events and community outreach programs
Minimum ten years clinical experience
Doctor of Medicine or Doctor of Osteopathy from an accredited school
Unrestricted License in Pennsylvania
Post residency clinical experience
Experience in Health Service treatment and program development
At least five years of management experience preferred
Experience in managed care setting preferred
Ability to implement medical policies, and to enforce those policies through appropriate action
Ability to maintain effective professional liaison with all levels of executive and medical staff, including professional and institutional providers of care. Ability to implement programs of quality care analysis, peer review, and professional education
Board Certification in ABMS American Board or Medical Specialists preferred
Act 73 FBI Clearance

Senior Medical Director, Lemtrada Team Lead Resume Examples & Samples

Support the US MS thought leader engagement/relationship-building. The Senior Medical Director is responsible for cultivating current and future MS experts in academic and clinical medicine at regional and national levels. Through these relationships, the Director will gain meaningful expert insights that influence priority areas of the product Life Cycle Planning in support of business, clinical and scientific strategy
This individual will oversee a team of approximately 3 medical directors; and will be responsible for mentoring, developing them as well as recruiting, hiring, and onboarding of new medical directors
Lead the development and implementation of the lemtrada medical team medical plan
Strategic and substantive input to publication planning and execution to ensure that all data on LEMTRADA in MS generated by company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner
Provide medical support, education and guidance to commercial, marketing and sales teams strictly following corporate compliance guidelines
Represent Genzyme at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with thought leaders
Maintain knowledge of MS market place, stay current on leading edge products development efforts and provide perspective to the business on the treatment landscape
Provide optimal collaboration for MS Medical Science Liaison (MSL) functions in the US such as education on MS, LEMTRADA development and the competitive landscape
Provide ongoing support for company sponsored trials in alignment with Clinical Development strategy. Ensure that conduct is in keeping with regulatory guidelines
Provide medical support to promotional and medical review committees as needed
Exemplify medical professionalism and ensure strict compliance in strict accordance to corporate SOP’s/guidelines
Drive ongoing support for company sponsored trials in alignment with Clinical Development Strategy. Ensure that study contact is in keeping with regulatory guidelines
Provide strategic and scientific input on alemtuzumab to the Medical Managed Care team for payer interactions and provide input into strategically aligned Health Education Outcome Research Projects
Through MS expert relationships, the Medical Director will facilitate the initiation of research projects and/ or phase IV studies. He/she will be responsible for the successful execution of appropriate processes for review, approval, management and support of studies while maintaining investigator independence according to regulatory and compliance guidelines
MD or PhD
At least 7 years of experience in the biotech or pharmaceutical industry in Medical Affairs, with experience working with cross-functional in-house and field-based teams
Neurology board certified/eligible preferred
Expertise in Multiple Sclerosis
Experience in both clinical development and/or patient care
Excellent interpersonal expertise with the ability to build solid cross functional working relationships
Demonstrated ability to work effectively in a matrix environment
An absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives

Senior Medical Director Resume Examples & Samples

O North America Medical ‘point of contact’ for the designated medicine(s) within the Oncology therapeutic area. Responsible for medical and scientific leadership and support to current and future commercialized medicines, and issues management for current medicines
Education and Experience -MD with clinical training and/or practice in Oncology preferred, with 5+ years of experience in Medical Affairs and/or Clinical Development roles. Additional clinical and/or industry experience especially in Oncology MA preferred. Required experience in the clinical drug development, regulatory processes, designing and conducting clinical trials preferred. Must be familiar with HEOR as it applies to achieving strategic business goals within his/her scope of work
Leadership - This individual must be able to inspire others, creating a dynamic environment that fosters transparency, collaboration and innovative strategic thinking. Must have proven track-record of success working across functions in a matrix environment with strong ability to influence and manage teams and stakeholders and an ability to foster teamwork across functions. Must have a strong work ethics and character is of the highest integrity, including strong ethical and scientific standards
Project Management -- Must have project and process management orientation and be able to drive multiple projects through effective motivation and collaboration; must be able to think through complex systems, and be able to see the vision and align/simplify these systems to achieve this vision
“Gets it done” Attitude -- This individual must be a practical thinker, able to identify simple, realizable solutions; he/she must also be able to identify and alleviate any potential hurdles to achieving objectives
North America Focus, International Scope -- Ability to interact with TEVA organizations in North America, Global functions, Israel and Europe

Senior Medical Director Resume Examples & Samples

Requires a Doctor in Medicine (MD) or D.O. from an accredited school of medicine recognized by national medical regulatory bodies in the United States
7+ years of experience is required in direct patient care and a strong working knowledge of managed healthcare
Qualifications to perform clinical oversight for the services provided by the health plan to include but not limited to: Education, training or professional experience in medical or clinical practice is required
Past participation in hospital managed care or medical practice UM committee is highly preferred
Intermediate proficiency in Microsoft Outlook, Word, Excel and PowerPoint

Senior Medical Director Resume Examples & Samples

10-15 years experience in the health care delivery system e.g., clinical practice and health care industry
M.D. or D.O., Board Certification in a recognized specialty including post-graduate direct patient care experience
Active and current state medical license without encumbrances
Experience directly supporting sales/client management
General Business/Demonstrating Business and Industry Acumen/MASTERY
Sales/Selling Products and Services/MASTERY

Senior Medical Director Resume Examples & Samples

Monitor the Utilization Review Program. Provide oversight, medical expertise administrative guidance to ensure that all Plan operations and goals for quality, value and cost management are met by the program
Establish and maintain up to date and industry-based utilization management performance standards
Provides oversight for the analytic activities of the division, including medical informatics, account reporting, predictive modeling and contract operations as it pertains to policy, pricing and provider analysis. Responsible for the analytic design for the corporate transformation strategy
Directs the provider profiling activities and serves as the medical director liaison to audit and recovery
Develop, implement and monitor clinical guidelines, protocols and programs that accomplish Plan objectives and that meet the medical needs of the member community and the financial needs of the provider community
Supervise and direct all physician-related activities, including oversight of work produced by staff Medical Directors
Chair and direct the Plan medical committees. Ensure all by-laws are followed, agenda items are completed according to established timeframes, and all issues relative to State, NCQA, CMS and other regulatory issues are achieved thoroughly and on a timely basis. Act as liaison to the Board of Directors and other entities as required and report on the activities of the Plan medical and accreditation committees
Other responsibilities as assigned
Current, unrestricted license to practice in Rhode Island
Eight or more years post-graduate experience in private practice with direct patient care
Three years experience as an Associate or Medical Director in a pre-paid health plan
Board Certification in ABMS certified specialty
Knowledge of CMS Medicare Advantage regulations, NCQA standards, RIDOH regulations
Knowledge of quality improvement principles and utilization improvement policies and methods to change provider behavior
Knowledge of finance and reimbursement methodologies
Managed Care
Analytics and Medical Informatics
Quality Contracting
Excellent Verbal and written communication skills
Exercise sound judgment
Take initiative in finding solutions to difficult and/or sensitive problems

Senior Medical Director Resume Examples & Samples

Develop the Reproductive Health and Women’s Health therapeutic areas and provide regular interaction with senior product and clinical management for strategic clinical development issues and clinical trial operations relating to R&D projects
Co-ordinate the scientific and medical aspects in clinical activities of the group in accordance with budget and agreed timescales to deliver Phase II-Phase IIIb (IV) Clinical Trials and all the clinical documentation for regulatory submissions and requirements in US
Provide medical expertise on all areas of Obstetrics and Gynecology to Research, Non-clinical, Regulatory, In-Licensing, Project Management, and Marketing for clinical development matters
Maintain relationships with external specialists
Ensure that all SOPs are followed and regulatory requirements are adhered to
Up to date knowledge within the therapeutic area and transmit this knowledge to the rest of the department and organisation
Provide technical scientific/medical consultation to ensure accuracy and compliance with FPI and FDA standards

Senior Medical Director, Psychiatry Resume Examples & Samples

Analyze and interpret data expertly, and clearly communicate results both internally and externally
Mentoring junior team members, and providing guidance and opportunity for their professional development
MD with at least five to seven years of pharmaceutical drug development experience
Expertise in Psychiatry, particularly treatment of schizophrenia and depression is preferrred
Direct experience interacting with regulatory authorities
Excellent verbal and written communication skills, a strong scientific background with industry drug development experience, and strong team leadership skills are required
Ability to work in a team environment with both internal and external (CRO) members
Experience in Clinical trial design specific to schizophrenia and/or depression
Familiarity with thought leaders in the field of treatment of schizophrenia and/or depression
Experience in design of proof of concept studies
Domestic and international travel (approximately 25%) is required

Senior Medical Director / Director, Oncology Resume Examples & Samples

Leverage professional network to cultivate new clients and new business opportunities
Develop/mentor medical advisors to build capacity and competencies
Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
Leadership, Teamwork, Customer Focus

Senior Medical Director Resume Examples & Samples

1 - 2 years' as a leader in a role that had direct reports and/or budget management
4 - 8 years' experience required in active clinical practice
Leadership Experience: Proven track record of chairing committees or successfully driving projects; demonstrated ability of leading a team and driving change in an organization
Clinical and Strategic Focus: Ability to develop and deliver an industry leading clinically focused strategy
Sustain rigorous pace of production while navigating competing priorities
Data Analytics: Analyze, synthesize, make recommendation and lead or be a part of an implementation team
Contextual adaptability: Easily modulates responses and reactions to current situation
Accountable: Takes ownership/responsibility
Fiscal Management: Analysis, organization and oversight of costs and expenditures for the organization

Senior Medical Director, Stroke Resume Examples & Samples

Excellent communication, leadership, and presentation skills
Experience in acute care and/or in neurology is a plus
10 years pharmaceutical experience is required

Senior Medical Director Resume Examples & Samples

Provides strategic and technical input to imaging biomarker development and implementation for both preclinical research and early clinical development projects with assigned TA
Establishes network of external imaging centers to assist team in conducting imaging studies
Work collaboratively and facilitate a cross functional group of MD and PhD’s and operational staff in order to efficiently and effectively enable the conduct of imaging studies across technological platforms, and geography
Build and maintain key stakeholder relationships with translational research into early clinical development (Interface with researchers in Drug Discovery Unit [DDU], Translational and Early Clinical Research [TREC], and Therapeutic Area Unit [TAU] teams)
Represent Imaging on Global Project Teams (GPTs), Translational (TSTs) and Clinical Sub-Teams (CSTs) to support imaging strategies and implementation plans
Support Imaging leadership in representing Takeda at imaging consortia, alliances, and collaborations
Partner with clinical operations, quality, procurement, and contracting groups to support study team implementation of imaging studies
Partners with Translational Biomarker Research, Quantitative Clinical Pharmacology, Pharmacogenomics, and other functions as appropriate to support the biomarker plan, and ensures that clinical imaging biomarker plan is supported by translational research data
Ensure that clinical imaging biomarkers results support data-driven clinical ePOC (early Proof of Concept) go/no-go decisions
Contributes to developing and testing companion diagnostics (CDx) strategy for later stage implementation
As an in house Imaging expert will work across all phases of development. Will work with clinical development teams plus other advanced technology groups and preclinical development teams to optimally devise and implement imaging biomarkers in drug development plans and clinical studies
Provide advice and recommendations to development teams about the appropriateness, utility, feasibility, limitations and benefits of various imaging techniques for use in POM/POC, profiling, registration trials
Ensure the proper implementation of imaging in clinical trials by scientific guidance on choice of imaging core lab and external imaging collaborators, by input into study protocols and imaging -specific trial documents, and by oversight of imaging -component conduct and imaging deliverables
Contribute to developing external relationships with key academic imaging centers , imaging diagnostics companies and imaging CROs
Minimum of 7-10 years of clinical imaging experience along with pharmaceutical drug development and translational/early clinical plan development
Cross-imaging modality expertise strongly preferred (MRI, PET, SPECT, CT, X-ray) including basic science knowledge of preclinical and clinical imaging modalities as well as design and implementation of clinical imaging trials
Superior analytic and problem-solving skills
Ability to engage in collaborative discussions on imaging biomarkers in innovative drug discovery from early preclinical through to late stage development
Ability to apply innovative imaging technologies in a “fit for purpose” manner in the drug discovery process
Knowledge of basic science
Ability to sit and stand for long periods of time
Carrying, handling and reaching for objects

Senior Medical Director Resume Examples & Samples

Reviews and analyzes medical records and supporting documentation for adherence to clinical standards of practice and applicable governmental or private policies and guidelines relating to medical necessity and appropriateness of services
Able to handle all case reviews as assigned, including complex cases independently and consults with and/or seeks advice from the Medical Director as appropriate
Summarizes key clinical facts of each case and prepares written justification for medical necessity decisions
Meets quality and regulatory standards for accuracy and timeliness of review
Meets individual productivity levels for assigned tasks, based on expected availability for review activities
If reviewer is up-to-date in the clinical area under review as shown by their experience, licensure, and requisite board certification, performs appeals considerations as directed by Medical Director
MD or DO degree or equivalent required
Field(s) of study: Graduate of an American Medical school accredited by the Accreditation Council for Medical Education (ACME) or with successful completion of the Educational Commission for Foreign Medical Graduates (ECFMG) and Federal 1

Senior Medical Director, Clinical R & D Resume Examples & Samples

Minimum M.D. degree and substantial medical/clinical training in Hematology/Oncology
Minimum 5 years of experience designing, leading and managing significant clinical trials in Hematology/Oncology
Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered

Senior Medical Director Resume Examples & Samples

Strategic alignment of the Cystic Fibrosis program working cross functionally and partnering with other key functions at Vertex such as Commercial, Regulatory, Market Access, HEOR, and Corporate Communications
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans, Life Cycle Management Plans and other key study documents in conjunction with other line functions and with minimal guidance
Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and marketed compounds; review clinical trials and community based grants, as needed
Set up and lead Steering Committee meetings and advisory boards
Partner with external investigators on Collaborative studies and with external registries on non- interventional studies using secondary data
Provide medical input and guidance to Managed Access Programs and individual compassionate access requests
Medical Degree (MD or DO)
Strong knowledge of internal medicine, pulmonary medicine, and/or other relevant speciality.. Experience in orphan diseases is a plus
Demonstrated clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
Experience in Medical Affairs within the biotechnology or pharmaceutical industry and/or experience conducting Phase 4 studies and non-interventional observational studies is an advantage
Proven ability to develop internal relationships in a highly matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts

Senior Medical Director Resume Examples & Samples

Facilitates strategic clinical relationships with physicians. Works with leadership to develop a strategic plan for growth of clinical practice
Implements utilization review and quality improvement systems. Implements educational programs and offerings
May provide medical services to patients in an assigned area
Serves as the subject matter expert for both management and education of individual providers in the Seton Insurance Services relationship regarding quality measures and performance standards. Maintains an effective infrastructure for quality and clinical programs, including data-gathering mechanisms, reporting formats, goals establishment, implement strategies and tactics. Reviews process improvement tools and techniques in order to identify areas for improvement; evaluates best practices from within and outside of the organization
Monitors the performance of network physicians with regard to the cost, clinical appropriateness and volume of authorizations. Collaborates with team members in the development, implementation, management, monitoring and evaluation of the effectiveness of programs to achieve preventative care targets. Analyzes network-wide and site-specific performance on quality and patient safety measures to identify opportunities for quality improvement and training
Advances Seton Insurance Services data governance and integrity toward systems that provide clinicians and leadership with information that helps them to assess the validity, quality and applicability of aggregated evidence gathered through the system; coordinates efforts to achieve meaningful use of health information technology
Oversees and manages all aspects of care management through the health plan; this includes the development of programs and services that improves the quality and efficiency of care delivered to health plan and ACO members. Oversees and manages all case management staff and programs that assist in the transition of members throughout the hospital and continuum of care; this involves active management of medical necessity denials, average length of stay, readmissions and transitions from an acute hospital stay to home or a post acute provider

Senior Medical Director Resume Examples & Samples

As an integral member of UPMC Health Plan's leadership team, serve as a 'role model' and 'health advocate' within the Western Pennsylvania community, including active participation with UPMC sponsored activities, public events and community outreach programs
Collaborate with VP, Medical Affairs and to engage all functional areas of the Health Plan from a clinical perspective to develop innovative programs as well as products lines; serving as the primary clinical liaison with Network Services, Strategic and Advisory Services, Finance and Underwriting, Operations, Information Systems, Pharmacy, and Product Development
Collaborate with Vice President, Medical Affairs, and Health Plan senior leadership in the development of short-term, mid-term, and long-range strategic planning for the Health Plan. Partner with physician leaders, and hospital and business executives to exceed clinical, operating, financial, quality, and market share objectives. Deliver executive level presentations for UPMC senior management and other designated groups
Collaborate with the VP, Medical Affairs and Chief Medical Officer to develop unique partnerships and differentiated relationships with current and prospective employer groups, consultants and brokers, in order to understand and meet their health and welfare needs
Create progressive physician group and provider education programs; direct concurrent education and communication related to credentialing, UM, and QI. The Senior Medical Director will be responsible for the Technical Assessment Committee (TAC).Establish and implement superior performance standards while maintaining compliance with applicable statutes, rules and regulations, the standards of accrediting bodies and corporate policies and compliance program standards
Identify opportunities to further integrate information systems and departmental interface capabilities, and from a clinical perspective, assist in affecting the 'phase-in' of newly acquired OAO interactive software
Influence medical cost trend in partnership with network services and medical management team, including development of trend-specific initiatives, provider fee schedule review, and identification of medical management best practices. Create opportunities to integrate pharmaceutical and medical strategy with innovative solutions
Interface with UPMC Health System cross-functional and shared resources to further the 'cause' to create a seamless healthcare patient-flow management process and insurance model
Lead the Utilization Management organization, Pod functions, as well as Quality of Care; leading management of 2nd level grievances, guiding and managing the most complex cases, appeals, quality regulatory requirements, credentialing, trouble-shooting and special investigations
Motivate and mentor UPMC Health Plan's clinical Medical Affairs staff by 'setting the pace' and fostering 'excellence by example'. Assess the overall team, including ongoing recruitment and hiring of talent. Ensure that the organization has the 'right people' in the 'right positions' and that the organization's structure is designed to maximize results
Nurture personal and professional growth/development by attending seminars, workshops, and establishing professional affiliations to keep abreast of latest trends in field of expertise
Passionately manage UPMC Health Plan's clinical Medical Affairs organization for Commercial, Medicare and Medicaid lines of business, to include; leading, educating and mentoring Medical Directors, managing all clinical aspects of Medical Management, Quality, Health Management, Utilization Management, Disease Management, Strategic Planning and Policy
Provide clinical leadership and support for Quality Improvement program, including study design for NCQA accreditation initiatives, coordination of HEDIS reporting, as well as meeting or exceeding all regulatory requirements. Serve as Clinical Leader for the UPMC for Life Medicare program
Serve as an integral part in the design and implementation of medical management initiatives such as disease management to improve quality and cost effectiveness of care delivered to Commercial, Medicare and Medicaid members
Serve on physician committees and work with each Health Management program to monitor, assess and ensure the program's clinical success. Establish best practices for care programs including Diabetes, Asthma, Congestive Heart Failure, End-Stage Renal Disease and Maternity Programs
M. D. Degree is required
Masters Degree is preferred in healthcare, marketing, business administration, or other related fields of study
Extensive experience in clinically leading Medical Affairs within a progressive managed care organization, ideally having created and driven innovative clinical program initiatives as well as having initiated NCQA accreditation and certification
Experience within a health plan that has truly developed a relationship with the physician and patient community; genuinely collaborative in nature, value-added versus commodity-driven, cross-functionally efficient and consumer-driven
A passion and commitment to help change the way healthcare is delivered, a track record of developing leading-edge Health Plan clinical strategies while motivating an organization to achieve stretch goals to drive innovation, and do what is right today, rather than tomorrow
Ability to lead, motivate and mentor superior Medical Directors in pursuit of progressive programming
Solicit support, evaluate, direct and hold ones self and employees accountable, while maintaining high morale and productivity during favorable and unfavorable conditions
Expert managed care clinical leadership skills, leveraging a broad knowledge base in managed care
Must possess a global understanding of the industry: legislative/regulatory developments, national product and delivery trends, maintenance of key industry relationships and tracking competitors
Highly developed interpersonal and communication skills, both written and verbal, and an executive demeanor which interacts effectively with all organizational stakeholders regarding sensitive and/or complex topics
Ability to plan and schedule multiple tasks/projects and to maintain control of ones own and others work flow to achieve results ahead of schedule and within budget
Highly developed analytical skills. Operates effectively in a matrix environment. Views the various matrix partners within UPMC as customers
Appropriate level of patience, and persistence, to move issues forward while competing in a highly complex, turbulent, and market-driven industry
Willingness and ability to delegate responsibility to senior subordinates while allowing them room to identify ways and means to take action and accomplish specific goals and objectives
Contributes imaginative and innovative ideas; encourages idea generation of others; open, accessible and communicative; sensible, fair and objective in decision-making; willing and able to confront difficult choices
Doctor of Osteopathy or Medical Doctor

Senior Medical Director Resume Examples & Samples

A history of Architectural Development of New Systems and Processes Within a Rapidly Growing Entity
A Passion for Elevating their Professionals' Understanding of Patient Satisfaction, Efficiency and Outcomes
Experience and/or Interest in Achieving Transformation for the Greater Good of the Patients and Organization We Serve
Flexible, with an Ability to Work in a Fast Paced Environment Which is Anticipating and Reacting to the Changing Landscape of Healthcare
Possess Exceptional Team Player Skills, Have the Ability to Work Harmoniously with a Diverse Work Force
Know How to Have Fun and incorporate it into your work day!
Doctorate Degree in Medicine
Board Certified In Internal Medicine, Emergency Medicine or Family Medicine
3-5 years' experience in progressively responsible Clinical and Management Roles
Experience Managing Clinical and Non-Clinical Staff
Experience in Monitoring, Managing and Coaching Professionals
A History of Architectural Development of New Systems and Processes with a Rapidly Growing Entity
A Track Record of working with Diverse Workforce and Bringing Harmony to the team
Active Unrestricted California Medical License
A willingness and ability to obtain other State Licenses
Active Unrestricted DEA Certificate
Active Unrestricted CMS (Medicare) and Medicaid (CA) Provider Numbers
Experience Managing Clinical and Non Clinical Teams
An Acute Understanding of Government Programs, compliance and adherence thereof
A Well Versed Understanding of HCC coding and the ability to teach

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MD or internationally recognized equivalent plus 8 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)
Participation in NDA/MAA/Submission experience
Track record and demonstrated ability to lead and manage both science and business aspects of drug development
Nonclinical and clinical drug discovery and development
TMS state-of-the-art technologies

Medical Director / Senior Medical Director Resume Examples & Samples

Leading Medical Safety Teams for assigned products in the evaluation, communication and management of safety signal and escalating important issues to Senior Management as appropriate
Overseeing safety aspects for clinical studies and working with clinical counterparts as needed to ensure appropriate study conduct from a medical safety perspective
Providing medical assessment of individual case safety reports (ICSRs) including causality assessment, determination of expectedness, identification of events of interest
Authoring relevant sections and conclusions of product safety profile for aggregate reports
Contributing to regulatory response documents
Managing external PV consultants and CROs and providing them with strategic leadership and oversight of safety monitoring
Contributing (writing, editing and reviewing) to the safety section of New Drug Application (NDA) submission documents and the clinical study reports
MD or DO. Board Certified/Board Eligible or equivalent with a 5 - 7 years experience in the pharmaceutical industry and at least 3 years focused on pharmacovigilance
Expertise in global pharmacovigilance and clinical safety regulations and guidelines
Ability to objectively interpret, analyze and communicate medical and scientific data
Experience with MedDRA and drug safety databases, such as ARISg
Strong communication skills both written and verbal
Ability to develop and maintain collaborative relationships

Senior Medical Director Resume Examples & Samples

Participates with colleagues in other Global Safety Functions in the development of a global consensus on signal detection tools and activities
Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 3 years in a global pharmacovigilance organization. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required
Relate well to people at all levels
Motivate and empower others
Project Management abilities
Able to manage both time and priority constraints and to manage multiple priorities simultaneously
Attention to details, computer literacy, knowledge of safety database
Take initiative and autonomous action

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