Medical Director, Medical Affairs Resume Samples
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Medical Director, Medical Affairs Resume Samples
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TS
T Sauer
Thurman
Sauer
219 Lauriane Groves
Boston
MA
+1 (555) 659 7416
219 Lauriane Groves
Boston
MA
Phone
p
+1 (555) 659 7416
Experience
Experience
Philadelphia, PA
Medical Director, Medical Affairs
Philadelphia, PA
Frami Inc
Philadelphia, PA
Medical Director, Medical Affairs
- Provide scientific support for medical educational initiatives, including facilitating the development of faculty speakers
- Collaborate with the field medical liaison team and support reactive material development to address their healthcare provider questions
- Develop and execute plans in alignment with regional plans of action
- Develop and execute strategy for the scientific utilization of the data generated by Seattle Genetics preclinical and clinical studies
- Develop a national medical affairs strategy for the countries in which reimbursement has been secured or is anticipated
- Provide scientific support at international and regional medical congresses
- Manage medical science liaisons who provide medical education and clinical support to physicians and thought leaders, and support medical training to field commercial personnel
Houston, TX
Medical Director, Medical Affairs Americas
Houston, TX
Thompson-Cole
Houston, TX
Medical Director, Medical Affairs Americas
- Ensures development and execution of strategic medical plans for post-marketed products, including MA-sponsored post- marketing studies
- Provides US medical affairs input into the global medical strategies of the assigned product
- Provides medical direction for Health Economic and Outcomes Research studies and initiatives
- Ensures development of strategic plans for post-marketed products and execution of Astellas sponsored post-marketing studies
- Initiates and potentially chairs Advisory Boards in Oncology
- Peer Group: Astellas Product Directors; MSL Therapeutic Area Director; Medical Directors in Global Medical Affairs
- Reviews Investigator Sponsored Research (ISR) proposals in Oncology
present
Los Angeles, CA
Associate Medical Director, Medical Affairs
Los Angeles, CA
Reinger Inc
present
Los Angeles, CA
Associate Medical Director, Medical Affairs
present
- Participate in the development of the US/global medical affairs plan
- Work closely with Takeda medical science liaisons (MSLs) with regard to scientific education, advisory boards, community clinical trial sites, interactions with community health care professionals and small/medium payer accounts
- Work with Global Oncology Business Unit (GOBU) leads to support US medical affairs activities
- Provide scientific expertise in the development of non-promotional and promotional materials
- Work closely with alliance partners and with clinical development and commercial
- Provide strategic assessments of opportunities and threats regarding the treatment of MM patients in the US
- Lead a broad range of medical affairs activities, including serving as medical monitor for US Takeda-sponsored medical affairs studies, internal training, and conducting advisory boards
Education
Education
Bachelor’s Degree
Bachelor’s Degree
Florida Atlantic University
Bachelor’s Degree
Skills
Skills
- Strong verbal and written communication skills at a professional medical level
- Knowledge of the immuno-oncology field in lung/solid tumors is a key
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines
- Ability to independently deliver quality results in a timely manner
- Team player with strong negotiation, problem-solving and strategic influencing skills
- Excellent German and English (written, oral) mandatory
- Excellent oral, written and presentation communication skills
- Established relationships with nephrology KOLs highly desired
- Ideal candidate will have worked in lung/solid tumor space
- Ability to travel 30-50%
15 Medical Director, Medical Affairs resume templates
Read our complete resume writing guides
1
Medical Director, Medical Affairs, Aubagio Resume Examples & Samples
- Experience in both clinical development and patient care
- Excellent interpersonal expertise
- Exemplary presentation skills
- Creative and innovative thinking
2
Medical Director, Medical Affairs, Aubagio Resume Examples & Samples
- Support the US initiative for MS thought leader relationship-building. The 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 team in support of business, clinical and scientific strategy
- Liaise regularly with internal business leaders to share feedback and issues from MS experts
- Support the development of Investigator Sponsored studies. Through MS expert relationships, the Medical Director will facilitate the initiation of research projects and ensure that hypothesis testing is clearly defined and within priority areas consistent with the strategic development objectives of teriflunomide in MS. 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
- Strategic and substantive input to publication planning and execution to ensure that all data on teriflunomide 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 Affairs support to the review of requests for grants and sponsorships. Ensure that review and approval processes strictly follow compliance guidelines
- In anticipation of product launch, the Medical Director will ensure that he/she and his/her team provide medical support, education and guidance to commercial, marketing and sales teams. Provide medical support to promotional and legal review committees as needed
- Represent Sanofi Genzyme at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with thought leaders
- Define and develop needs analyses for MS Medical Science Liaison (MSL) functions in the US to ensure that those carrying out the MSL function are optimally educated to be experts on MS, teriflunomide development, and the competitive landscape
3
Medical Director & Medical Affairs Lead Resume Examples & Samples
- Provide medical governance and strategic leadership over all medical activities for the relevant mission, by establishing superior partnerships, both internally and externally, by growing and communicating the knowledge and value of our patient solutions throughout their lifecycle
- Ensure that patients benefit fromtreatment options based on compelling evidence and unique medical insights
- Contribute to the generation and execution of the Clinical Development Plan(s) leading to successful registration and launch of NCEs/NBEs and additional approvals of new line extensions (indications or formulations) of registered compounds
- Contribute to the design, conduct and interpretation of specific clinical trials, specifically their relevance for the target disease(s) and drug candidate(s)
- With the Benefit Risk Team, ensure the study-related safety of the subjects in the clinical trials through appropriate safety signal detection and medical monitoring of studies on an ongoing basis – with or without independent data and safety monitoring boards
- Collaborate with relevant UCB departments in order to follow-up the operational implementation of assigned trials or clinical development program(s)
- Establish and maintain credibility of the Global Immunology Therapeutic strategy while interacting with other internal departments and external experts for the assigned area(s) of responsibility
- Contribute to the clinical section of documents including, but not limited to, the Investigator Brochure (IB), Annual IND Safety Updates/EU Annual Reports, Clinical Study Reports, and submission related documents such as the Clinical Summary of Efficacy and Safety and the Clinical Overview
- Maintains excellent working relationships and global cross functional collaboration
- Assume responsibility for correct and updated medical/scientific information for the respective therapeutic field and ensures its incorporation into the Clinical Development Plan (CDP)
- Assure medical/scientific integrity of clinical development programs and their deliverables (e.g. protocols, clinical study reports, etc.)
- Entrepreneurial, positive with a can-do attitude
- Energetic, dynamic, proactive & results driven
- Able to build strategic highly networked working relationships with both diverse internal and external experts, as well as brand team members
- Ability to lead cross-functional meetings & projects across matrix and geographies
- The ability and flexibility to have significant global travel (approx. 30%), including international
- A connector and team player, who can create strong relationships and liaise with major stakeholders in functions both internal and externally
- Strong project management skills, including projects managed via a matrix organization
- Excellent interpersonal and communication skills with individuals with different cultural, professional and academic backgrounds
- Strong strategic mind-set and the ability to think based on both business and scientific principles
- Self-motivated, proactive problem solver
4
Medical Director, Medical Affairs Americas Resume Examples & Samples
- Ensures robust US Medical Affairs strategic plans are in place for the assigned compounds in Oncology that are aligned with the Global Medical strategies
- Potentially leads MA-sponsored clinical studies
- Aligns closely with peer colleagues in the US Commercial part of Astellas and participates in cross functional teams
- Provides US medical affairs input into the global medical strategies of the assigned product
- Reviews manuscripts and abstracts
- Reviews promotional materials through the MAP Process
- Initiates and potentially chairs Advisory Boards in Oncology
- Reviews Investigator Sponsored Research (ISR) proposals in Oncology
- Reviews and approves Medical Information letters and slide decks
- Provides medical affairs input in new product licensing and acquisition opportunities for marketed and late-stage compounds that are targeted specifically for the US market when requested
- Monitors budget and timelines, ensuring effective fiscal utilization per budget
- Ensures development of strategic plans for post-marketed products and execution of Astellas sponsored post-marketing studies
- M.D. degree (required). Minimum 3-5 years clinical experience
- Minimum 2 years Medical Affairs relevant experience working in the
- Experience in managing relationships with medical, clinical, regulatory, health outcomes, epidemiology, medical information, and other organizational partners
- Strong scientific analytical and problem solving skills, strategic capabilities,
- Strong problem solving in a complex multi-track partnership environment
- Strong leadership and problem solving ability is the must
- Ability to lead a matrix structured product team across multiple disciplines in
- Knowledge of regulatory bodies and procedures, as well as anti-kickback laws,
5
Medical Director, Medical Affairs Resume Examples & Samples
- Manage medical science liaisons who provide medical education and clinical support to physicians and thought leaders, and support medical training to field commercial personnel
- Identify local national/regional thought leaders in oncology and urology and establish/ maintain scientific relationships with them
- Develop a national medical affairs strategy for the countries in which reimbursement has been secured or is anticipated
- Act as primary contact for investigators interested in developing and performing studies with the company’s commercially available assays in oncology and urology
- Lead national/regional advisory boards to seek external advice
- Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider setting in both group and one-on-one situations
- Develop and execute plans in alignment with regional plans of action
- Support investigator initiated and collaborative studies including study design discussions, protocol development, study operations, analysis, and preparation of abstracts and publications
- Provide Scientific and Medical presentations and dossier reviews for regional and national reimbursement objectives
- Provide scientific support at international and regional medical congresses
- Provide scientific support for medical educational initiatives, including facilitating the development of faculty speakers
- Provide medical review and edits for all German language medical, educational and promotional materials
- Provide feedback and medical input to local commercial plans and strategies
- At least 3-5 years of industry experience
- Entrepreneurial skill set, capable of working well in self-directed manner across small, cross-functional teams
- Therapeutic experience/expertise in oncology (breast cancer in particular) or diagnostics preferred
- Preferably possesses an established relationship network of physicians involved in treating breast cancer in Germany
- Excellent German and English (written, oral) mandatory
- Skills in multiple languages preferred
- Excellent oral, written and presentation communication skills
6
Medical Director, Medical Affairs, Neurology Resume Examples & Samples
- Leadership of the Medical program for a novel product in development for migraine prevention
- Lead in the development, execution and communication of the US Medical Team (USMT) product plan
- Serve as the primary Medical point of contact in the launch planning process to ensure alignment between medical and brand activities
- Supporting data generation in the US (including Ph4, HE, Observational, Comparative Effectiveness, and Non-Amgen Sponsored Clinical Research (NASCR)) in partnership with Development Operations, the Center for Observational Research and Global Health Economics
- Partnering with the Amgen Therapeutic Area (TA) field-based, Regional Medical Liaisons (RMLs) and HOPE (Health Outcomes and Payer) RML teams to foster and cultivate relationships with the external clinical community, including interactions with opinion leaders, payers and medical societies for scientific exchange
- Supporting the execution of the US advocacy plan in partnership with Scientific Affairs, US Value & Access, and Global Development
- Providing US-focused medical input into global Development strategy, study design and deliverables (i.e., protocol, CSR, manuscript)
- Assisting in the review US IME, donation and sponsorship requests, aligned with global strategy
- MD, board certified or board eligible in Neurology or related discipline
- 5+ years of industry experience, with experience leading a product (pre-approval or in-line) Medical program
- Experience in product launch in Neurology or related field (e.g. pain management)
- Accredited fellowship in Neurology, preferably in Headache but other relevant experience will be considered
- 2+ years of clinical research experience in Neurology or related field (industry or academic)
- Experience with opinion leader interactions, publications planning, data generation activities, and promotional review
- Broad and formal leadership experience, preferably in a matrix environment
7
Associate Medical Director, Medical Affairs Resume Examples & Samples
- Work with Global Oncology Business Unit (GOBU) leads to support US medical affairs activities
- Provide scientific expertise in the development of non-promotional and promotional materials
- Foster research relationships with community hospital centers and key US community oncologists
- Interact regularly with key medical opinion leaders
- Responsible for US thought leader development
- Active US MD license required
- Ideal candidate will have worked in community hospital setting
- Minimum of 2 years combined post-clinical MD/industry experience
- Must have conducted or participated in clinical trials with track record of patient accrual
- Must have experience in hematology and oncology
- In-depth understanding of the multiple myeloma research environment and the immuno-oncology field is a key plus
- Requires experience and success in working in a matrixed, cross-functional environment; excellent collaboration skills; experience working across functions to achieve results
8
Medical Director Medical Affairs Resume Examples & Samples
- Physician, ideally with specialist qualification relevant to Respiratory
- Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements
- Ability to develop, design and implement Phase 3b /4 studies
- Significant experience in Medical Affairs and life cycle management preferred, including understanding of launch support requirements
- Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes
- Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment
- Demonstrated ability to build strong networks of external and internal experts
- Contribute to the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/ indication(s) under the direction of the Global Medical Affairs Leader (GMAL)
- Work closely with the Physician Project Leader (PPL) and Medicine Development Leader (MDL) to optimise development plans
- Lead/contribute to designated elements of the above-country Medical Affairs Plan e.g. Advisory Boards; Symposia
- Partner with commercial colleagues to develop brand campaigns and support launches
- Develop and approve promotional, non-promotional and training materials
- Deliver the evidence needs of that asset in partnership with Franchise/ R&D colleagues, including: o Supporting the efficient working of the Integrated Evidence Team
- Supports the GMAL in gathering medical insights from the Franchise LOCs and external takeholders (HCP’s, Patients, Payors and Regulators) to shape the integrated evidence strategy and plan
- Leads aspects of Advisory Board design and discussion, as requested by the GMAL, ensuring compliance with SE governance and documentation requirements (SE Approval Templates; GLASSES etc)
- Inputs to the design and delivery of phase 3b/ 4 studies, coordinating with relevant R&D technical experts e.g. Value Evidence & Outcomes and Epidemiology as required
- Supports preparation of materials for the Portfolio Investment Board review/ Brand Planning processes
- Develops and approves promotional campaigns and materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc)
- Develops and reviews publications/ abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DPP) is maintained in Datavision
- Supports the GMAL in providing medical governance oversight for the asset, including the management of product-related issues/ crises
9
Medical Director, Medical Affairs Resume Examples & Samples
- Develop and execute strategy for the scientific utilization of the data generated by Seattle Genetics preclinical and clinical studies
- Work with the Senior Medical Director and other directors to serve on project teams as Medical Affairs representative and medical expert
- Participate in a cross-functional medical affairs team with the goal of developing and implementing an integrated medical strategy for Seattle Genetics products
- Collaborate with the field medical liaison team and support reactive material development to address their healthcare provider questions
- Collaborate with MA Operations group to evaluate and manage Investigator Sponsored Trial efforts
- Collaborate with Medical Information specialists on the development of medical information letters and documents
- Provide appropriate medical input for MA activities
- Literature review and summaries to support MA activities
- Help identify and effectively interact with thought leaders to engage in scientific and medical exchange to meet the needs of oncology patients and advance the field of study
- Serve as a reviewer on the Medical, Regulatory, Legal, Non-promotional review (MeRLeN) panel
- Serve as medical lead on strategy and conduct of Phase 4 studies
- Lead and coordinate assigned projects and related medical aspects
- Assure appropriate close coordination with Commercial and Marketing teams to support their efforts
- Coordinate with Clinical and Translational Medicine teams on strategic priorities and study support
- Assist as needed in preparation of manuscripts, abstracts and presentations for scientific meetings
- Experience and understanding of oncology drug development
- Previous pharmaceutical industry experience strongly preferred.Prior medical affairs experience a plus but not required
- Medical degree with solid tumor oncology background (ideally ABIM-certified)
- Ability to think strategically, good leadership skills
- Good communication skills, fluent in English
- Ability to work in a fast-paced and ever-changing environment
- Proven track record of working effectively in diverse teams involving multi-functional disciplines
- Strategic thinking and prioritizing capacity
- Business and customer oriented
- Analytic and synthetic capacity
- Ability to understand and simplify scientific concepts
- Innovation/Creativity
- Ability to work in an international matrix organization
- Interpersonal/communication skills ability to address the scientific and non-scientific community as a target group
- Team spirit and teamwork ability
10
Senior Medical Director, Medical Affairs Resume Examples & Samples
- Partner with opinion leaders (OLs) to gather information on current focused therapeutic area issues and questions
- Provide clinical leadership in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Development, and Commercial)
- Work closely with Medical Science Liaisons (MSLs) to provide appropriate education and training. Provide support, participation and insight in MSL activities, such as KOL interactions
- Provide medical expertise to the Medical Information group and Medical Communications group; participate in a cross-functional team that identifies and addresses emerging medical inquiries; reviews documents created to support Medical Affairs external communications
- Provide medical support to promotional and legal review committees
- Provide medical support as needed on non-company sponsored studies, non-interventional studies and investigator sponsored studies
11
Medical Director, Medical Affairs Americas Resume Examples & Samples
- Ensures robust US Medical Affairs strategic plans are in place for the assigned compounds in the Therapeutic Aea that are aligned with the Global Medical strategies
- Leads MAA-sponsored clinical studies as needed
- Provides medical direction for Health Economic and Outcomes Research studies and initiatives
- Communicates effectively, including detailed scientific concepts, both in writing and in oral presentations
- Aligns closely with peer colleagues in the Astellas US Commercial organization and participates in cross functional teams
- Ability to lead a matrix structured product team across multiple disciplines in support of TA
- Is member of the Publication team; reviews manuscripts and abstracts
- Accountable for medical content review of promotional materials through the defined governance process as needed
- Initiates (and potentially chairs) advisory boards in the TA
- Reviews investigator sponsored research (ISR) proposals in the TA; may Chair Regional ISR Committee
- Reviews and approves Medical Information letters and non-promotional medical materials
- Provides medical affairs input in new product licensing and acquisition opportunities for marketed and development compounds that are targeted specifically for the US/Regional market when requested
- M.D. or D.O. degree or equivalent
- Minimum 3-5 years clinical experience
- Minimum 2 years Medical Affairs relevant experience working in the pharmaceutical industry, /or minimum 3-5 years clinical or academic experience after residency training
- Experience in collaborating with medical, clinical, regulatory, health outcomes, epidemiology, medical information, commercial and other organizational partners
- Strong scientific analytical and problem solving skills, strategic capabilities, project management and planning and organizational skills
- Ability to communicate effectively, including scientific concepts, both in writing and in oral presentations
- Ability to critically review ISR proposals
- Ability to effectively influence both internal and external stakeholders, customers and collaboration partners
- Demonstrated ability to collaborate and build strategic alignment within the Medical Affairs community and across functions (e.g. with US Commercial)
- Knowledge of regulatory bodies and procedures, as well as anti-kickback laws, which could have impact for the pharmaceutical industry. Appropriate knowledge of guidelines such as IFPMA (International Federation of Pharmaceutical Manufacturers Association) and PhRMA (Pharmaceutical Research and Manufacturers of America
- Fluent in written and verbal English
- Ability to travel for business
12
Lead / Medical Director, Medical Affairs Resume Examples & Samples
- Develop and implement reliable and high-value communication strategies for new products
- Successfully create a bridge between clinical development teams and provide medical expertise to the commercial product development teams
- Neuroscience clinical trial research experience conducted in a pharmaceutical or equivalent environment is strongly desired
- U.S. Medical Affairs and U.S. marketing experience, to include a well-documented history in medical development of neuroscience therapeutics and of bridging proactive relationships among product development, clinical development and marketing teams
- Previous medical role in new product launch is desirable
- Working knowledge and or experience in managing chronic conditions including pain, understanding of symptomatic treating approaches , disease management and burden on patients desirable
- Excellent oral and written communication skills. Track record of meaningful contributions to scientific literature in NS or similar
- Experience leading large projects/organizations, process management and collaboration management will be an asset
- Ability to travel (U.S. and Europe; 20-25% annually)
13
Medical Director, Medical Affairs Resume Examples & Samples
- Lead medical and scientific TA/product initiatives within a matrix environment including oversight and execution of Medical Affairs Company Sponsored Studies (MACS) and Health Economics and Outcomes Research (HEOR)
- Provide scientific insight and medical expertise in the development of medical, research and commercial strategy for assigned compounds by participating in and leading cross functional committees
- Either directly, or indirectly, oversee the medical review and sign off of promotional pieces in support of the Medical-Regulatory-Legal committee for products within the specific therapeutic area
- Develop and maintain relationships with relevant Professional Associations to further develop the profession, education and create visibility and awareness for Takeda
- Provide medical direction and review for pre and post launch regulatory strategies (which may include label (PI), protocols, Supplemental NDA’s, etc)
- Participate in the publications strategy for assigned compounds by providing scientific and publication planning input
- Perform medical and scientific review of investigator initiated study proposals, as required
- Provide input to confidential New Business Development opportunities within the respective therapeutic area of expertise, as required
- Provide support for departmental initiatives that further our business, and support other departments within Takeda such as Managed Markets, Marketing, New Product Planning, Government Affairs, SPP (TPC), and some R & D related projects, etc
- Collaboration with field medical teams
- MD degree with at least 7 years of relevant clinical practice, research, academic and/or pharmaceutical industry experience
- Experience with clinical research, publication activities, congress presentations, and public speaking
- Board certification in therapeutic area related to the position
- Medical Affairs or R&D experience
14
Medical Director, Medical Affairs Resume Examples & Samples
- Develop an in-depth understanding of the needs of oncology patients and demonstrate a focus on activities to meet those needs
- Participate in the development of the US/global medical affairs plan
- Work closely with Takeda medical science liaisons (MSLs) with regard to scientific education, advisory boards, community clinical trial sites, interactions with community health care professionals and small/medium payer accounts
- Work closely with alliance partners and with clinical development and commercial
- Provide strategic assessments of opportunities and threats regarding the treatment of MM patients in the US
- Lead a broad range of medical affairs activities, including serving as medical monitor for US Takeda-sponsored medical affairs studies, internal training, and conducting advisory boards
- Provide medical leadership for investigator initiated studies (IIS) program
- Ideal candidate will have worked in lung/solid tumor space
- Minimum of 5 years combined post-clinical MD/industry experience
- In-depth understanding of the lung cancer research environment
15
Senior Medical Director, Medical Affairs Resume Examples & Samples
- Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events and Serious Adverse Events if assigned to AbbVie conduct on clinical studies
- Oversee scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource
- Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. Works independently. Can address complex problems within discipline or across several projects. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions. Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors
16
Medical Director, Medical Affairs, Oncology Resume Examples & Samples
- Board Certified in Oncology and 3 years post US fellowship training OR MD with 5-7 years experience in oncology within the pharmaceutical industry OR PhD or PharmD with 5-10 years experience in oncology within the pharmaceutical industry
- Expertise in solid tumors is required, HCC specific experience is preferred
- Clinical research experience, including conducting oncology clinical trials in the Phase II-IV area
- Experience reviewing promotional materials from a medical perspective, publications planning, relevant medical society membership and track record of active participation/attendance, and public speaking experience
- Experience working with cross functional medical and commercial teams
17
Senior / Medical Director, Medical Affairs Resume Examples & Samples
- Provides global coordination of all Global Medical Affairs function related to a compound or disease area specific area
- Leads the Product or Disease Area Matrix Team
- Responsible for direct management of projects and project associated personnel
- Responsible for the development and implementation of Global/Regional Medical Plan Plan in coordination with GMAF stakeholders, RML, AML, clinical sciences (project team lead), product development (core team lead), commercial (global commercial lead) and other relevant stake holders
- Responsible for providing medical input into development, execution and interpretation of Phase I, II, III and IV clinical protocols. This includes review of draft IR protocols, reports and manuscripts
- Responsible for direct interaction with investigators, KOLs and the research community to support company initiatives
- Act as a key member of the Core team/Project team, IRRC, PRB, MMRC and MPRC reviews
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources
- 2+ years experience in pharmaceutical or biotech industries, Medical Affairs experience preferred
- 2+ years as a medical monitor on company sponsored trials is preferred
- Clinical trial and publication experience essential
- Knowledgeable and current in GCP guidelines in US and Canada
- 30-40% travel requirement and may include weekends
18
Medical Director, Medical Affairs Resume Examples & Samples
- Develop and execute strategy for the scientific utilization of the data generated by Akebia, including development of the medical affairs data generation plan
- Provide support to clinical operations for new or existing investigators in clinical trials, investigator-sponsored trials, and registries
- Help identify and effectively interact with thought leaders to engage in scientific and medical exchange
- Participate in appropriate cross-functional and cross-company teams to represent Medical Affairs, including teams related to Akebia’s external partnerships
- Lead the review and assessment of investigator-initiated study proposals or other collaborative studies as appropriate, including the development of medical strategy governing investigator initiated research
- Provide medical input into publication activities, including the medical review of publication plans, abstracts, and manuscripts
- Collaborate with Medical Communications Director to develop content and strategy for medical education content and advisory boards
- Advanced degree (PharmD, MD, DO, PhD, MS) in science-related field required with 3 years of relevant experience
- MD with 3+ years of Global Medical Affairs experience strongly preffered
- Familiarity with GCP/ICH/FDA/OPDP (formerly DDMAC) requirements as well as clinical trial design, biostatistics, product safety, and regulatory affairs preferred
- Experienced in presenting at investigator meetings, advisory boards and medical and scientific conferences
- Established relationships with nephrology KOLs highly desired
- Full understanding of all stages of pharmaceutical drug development process, from pre-launch through commercial/development lifecycle
- Strong verbal and written communication skills at a professional medical level
- Team player with strong negotiation, problem-solving and strategic influencing skills
19
Associate Medical Director, Medical Affairs Resume Examples & Samples
- Foster research relationships with academic key opinion leaders, community hospital centers and key US community oncologists
- Medical Degree Ideal candidate will have worked in lung/solid tumor space
- Minimum of 2 years combined post-clinical MD and/or industry experience
- Must have experience in medical oncology
- Knowledge of the immuno-oncology field in lung/solid tumors is a key plus
20
Senior Medical Director Medical Affairs Resume Examples & Samples
- Serve as medical and scientific medical affairs expert for assigned asset(s); develop and communicate key medical data elements and medical messages to respective colleagues, assist with medical training, medical information services, global medical communication and publication planning and execution
- Represent medical affairs at company and alliance meetings; coordinate medical input from affiliates and alliance partners
- Interact internally with and support colleagues from Alliance Management, Business Development, Government Affairs, Marketing and Sales with Sunovion US, and DSP.. Develop and maintain relationships with key external experts through Professional Associations, Professional Meetings and Conferences, etc. in support of common scientific objectives
- Seek input and alignment with key internal stakeholders on therapeutic area initiatives (e.g, research gap analysis, communication plans, novel indications, etc.)
- Manage the budget for the specific Cost Center
- Provide medical and scientific direction and review for pre and post launch regulatory strategies (which may include label (PI), protocols, NDAs and Supplemental NDA’s, etc)
- 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 assigned assets
- Coordinate publications and communications strategy between affiliates 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 medical affairs activities for assigned assets
- MD degree with current or recent board certification in a related specialty
- 5 plus years of experience in industry and/or academic research experience; or equivalent combination of experience
- Prior experience in Global and/or US Medical Affairs
- Experience in ADHD and related disorders
