Associate Scientific Director Resume Samples

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D Parisian

Daniella

Parisian

9367 Blanda Branch

New York

+1 (555) 110 1645

9367 Blanda Branch

New York

Phone

p +1 (555) 110 1645

Experience Experience

Phoenix, AZ

Associate Scientific Director

Phoenix, AZ

Hudson and Sons

Phoenix, AZ

Associate Scientific Director

Develop and implement scientific and functional assay strategy for the biologics Lead Optimization team
Lead a team of scientists in the design, development and execution of assays for biotherapeutics lead optimization characterization and candidate selection
Collaborate with colleagues in the Biologics Research department, across Janssen Biotherapeutics and with our partners in the therapeutic areas in a cross-functional team environment to drive an innovative biologics portfolio
Work with upstream and downstream partners for efficient and seamless project phase transitions
Effectively communicate (written and verbal) scientific data, analysis and interpretations to contribute to lead candidate selection decisions
Ensure flawless execution and compliance for the Lead Optimization assay team
Interacting with biologic and discovery research teams, to address key development questions, design experiments and analyzing the results and provide strategic direction to help identify those compounds that have the greatest chance of success for further development or to stop development programs

New York, NY

Associate Director, Scientific Computing

New York, NY

Emard Inc

New York, NY

Associate Director, Scientific Computing

Stay abreast of the latest technology and methods for scientific computing and high performance computing
Work closely with IT to maintain Biogen's quality and scale of compute and storage infrastructure
Operationalize development projects into production quality tools in the existing research compute ecosystem for use by scientists
Lead evaluation, selection of, and work with outside vendors to design and implement solutions, as well as integrate them into internal pipelines
Stay up-to-date and be familiar with new high performance computing technologies and anticipate and exploit use of new technologies that impact decision making in drug discovery
Lead and develop a diverse team of experts, including contractors and direct reports, in bioinformatics, high performance computing, cloud computing, image analysis, and related scientific computing disciplines
Negotiate and manage a software and contractor budget that will vary annually

present

Los Angeles, CA

Associate Scientific Director, GI DDU

Los Angeles, CA

Donnelly-Pagac

present

Los Angeles, CA

Associate Scientific Director, GI DDU

present

A scientific research leader within the GI Drug Discovery Unit, working within a highly matrixed & virtual environment, contributes to building a robust preclinical and early clinical pipeline in gastroenterological diseases
Plays a key role in translational research activities in partnership with Translational Research & Early Clinical research team and expert external groups
Identifies, establishes and ensures the success of key external collaborations targeting and developing novel therapeutic approaches to GI disorders, focused on stem cell therapy approaches to enteric neuropathies, inflammatory disorders and liver diseases
Builds relationships & collaborates with scientific leaders, KOLs, academic partners, CROs and biotech companies and is seen as an international subject matter expert in GI research and therapeutics
Seeks and proposes preclinical and clinical in licensing candidates and provides expert input to their evaluation
Is a member of the GI matrix team and contributes to strategic decisions to advance research projects from early stages to developmental stages in a way that maximizes the likelihood of long term success (POC and beyond)
Identified as a Global Takeda thought leader in GI disease research and provides subject-matter expertise, with an emphasis on GI motility disorders

Education Education

Bachelor’s Degree in Chemistry

Seton Hall University

Bachelor’s Degree in Chemistry

Skills Skills

Experience in, or ability to understand, multiple therapeutic areas and quickly come up to speed in new therapeutic areas
Excellent interpersonal communication skills, able to drive global collaborations in cross-functional, multi-cultural organizations
Proven ability to design and develop viral vaccines, including scientific accomplishment in virology, molecular biology, immunology or related field
Careful attention to detail, especially with regard to the accuracy of data and other scientific content
Excellent oral and written communication skills that includes skill in writing, reviewing, and editing scientific documents
Ability to effectively influence colleagues and multi-disciplinary project teams
In depth, expert knowledge and application of advanced pharmacokinetics and pharmacodynamics as well as interpretation of complex data and statistical analyses
Ability to work concurrently on several complex projects, meet aggressive deadlines, and adjust priorities rapidly as a situation demands
Significant industry experience and working knowledge of GLP practices
Experience in interpreting clinical data with an ability to communicate an understanding of that data both verbally and in writing

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Associate Scientific Services Director Resume Examples & Samples

Life science degree
5 years' minimum agency experience with a focus on medical publications
Proven ability to successfully drive results through others
Strong people management skills
Oncology experience
Advanced degree in life sciences, pharmacy or medicine (PhD, PharmD, MD)

Associate Scientific Director Resume Examples & Samples

Ph.D. degree with at least 8 years of experience in biologics drug discovery or relevant field is required
Expertise in protein therapeutics and functional characterization, assay design and development (ie: cell based bio-assays, biochemical assays, Fc effector function characterization) are required
Previous people manager/leader experience is required
Industry experience is preferred
Experience in Immunology and/or Oncology is preferredR&D

Associate Scientific Director, Toxicology Resume Examples & Samples

A PhD or DVM degree in Toxicology or related life science with a minimum of five years of industry experience is required
DABT certification is preferred
Experience in small and large molecule development is preferred
Proven ability to design toxicology programs, provide functional expertise for drug development teams is required
A record of designing and monitoring GLP toxicology studies conducted at contract laboratories, scientific data evaluation, integrated safety assessment, scientific writing for reports and regulatory submissions (e.g., IND, IBs and CTA) and participation in regulatory meetings is required
Demonstrated participation as a functional representative on cross-functional discovery and development project teams is required
Strong written and verbal communication skills along with strong critical thinking skills are required
Broad scientific knowledge in toxicology, pathology and DMPK, and an ability to apply this knowledge to influence development programs are required
Experience in the therapeutic areas of antiviral and oligonucleotide is preferred
This position is located in South San Francisco, CA and may require up to 25% travel.R&D

Associate Director, Scientific Licensing Resume Examples & Samples

Key member of the Oncology Licensing Team within Janssen Business Development and responsible for contributing to the TA business development strategy in alignment with the over-arching TA strategy
Accountable for execution of the TA business development strategy including identification of target opportunities and companies (leads the process by which systematic screening in areas of interest is performed such that no opportunities are missed)
Building strategic and scientific relationships with representatives of target companies and with KOLs
Leading the scientific evaluation of target opportunities (including the coordination and management of the formal due diligence process) across the R&D matrix
Collaborating with commercial assessment team to provide scientific input to commercial assessment and ensure scientific evaluation addresses key value drivers
Responsible for establishing and developing key stakeholder relationships in R+D leadership, identifying internal scientific champions for business development opportunities and managing the upward scientific communication of external opportunities
Accountable for ensuring that all business development opportunities progressing to contract negotiation and beyond meet the internal portfolio standards of scientific excellence, that development risks are identified, adequately communicated and debated with R+D leadership and that mitigation strategies are captured and accounted for in the development plans and costs
In collaboration with the TA department heads and the VP Licensing for Oncology, responsible for ensuring that R+D resources are engaged in an orderly, efficient, timely and cost-effective manner in the evaluation of licensing opportunities for the TA
In collaboration with other JBD colleagues, contribute to the development and enhancement of processes, templates and data capture systems to be utilized by the business development group to attain the highest professional standards in the execution of duties
A minimum of a Bachelor’s degree required. MD or PhD is Preferred
Minimum of 5 years of experience in Drug Discovery or Drug Development with a large portion of that experience being gained in an industry setting is required
Pharmaceutical experience required
Academic experience also of potential interest / research within disease area preferred
Expertise within oncology therapy area is preferred
Experience in participating on scientific due diligence teams is preferred
Work experience in business development or previous position in licensing is preferred
This role will be based in Springhouse or Raritan. Must have the ability to work from both locations
This role requires up to 40% domestic and international travelMergers (SP)

Associate Scientific Director Resume Examples & Samples

Interacting with biologic and discovery research teams, to address key development questions, design experiments and analyzing the results and provide strategic direction to help identify those compounds that have the greatest chance of success for further development or to stop development programs
He/She will conduct advanced pharmacokinetic analysis, apply PK/PD modeling concepts, and assess basic research on PK, target engagement, receptor occupancy, antidrug antibody and ADME for biologic drug candidates
He/She will write and/or review technical reports, and be involved in drafting preclinical PK and related sections in an IND or CTA
PharmD or PhD in Pharmacology, Pharmaceutical Sciences, Biochemistry, Biology, or equivalent with at least 3 years of pharmaceutical research and development experience in various aspects of pharmacokinetics, modeling and simulation, biologics and pharmacology
Experience with at least one of the following PK/PD software applications: NONMEM, ADAPT, SPLUS, R, WinNonlin and/or other modeling and simulation software is required
Experience in research and development of biologic therapeutics is required
Preclincal research experience in biology or pharmacokinetics is preferred
Experience writing submissions and drafts for INDs or CTAs is preferredPharmacokinetics

Associate Director, Scientific Affairs Resume Examples & Samples

Participates as a member of the Due Diligence (DD) team from kick-off through close-out, to evaluate target opportunities with a CMC sub-team, looking for risks and opportunities in the area of API and Finished Product characterization/evaluation and any other aspects based on QbD which could impact the successful development, filing and commercialization of the target asset
Prepares DD reports to summarize the findings into a concise evaluation of possible risks and opportunities, and a prioritized, actionable plan and mitigation strategy
Seeks input from other functional area Subject Matter Experts (SMEs) to build teams with the appropriate expertise as required to perform target evaluations, while maintaining confidentiality requirements of due diligence
Provides timely updates to the Scientific Affairs and BD&L leadership
Represents Sandoz to the target companies in a professional and competent manner, supporting our value proposition as the “partner of choice” to potential partner companies
When needed works with IP Legal to assess potential CMC IP opportunities
12 years’ experience in the Pharmaceutical Industry preferred with a broad exposure to various dosage forms development, CMC aspects of product development and commercialization, and Sterile product development (ANDA/NDA)
Some business development and previous due diligence experience is desired

Associate Director, Scientific Affairs Resume Examples & Samples

Ability to travel up to 65% as required per this position
The ideal candidate will reside within the position territory
Minimum of 3 years of oncology therapeutic area experience or 3 years Medical/Scientific Liaison is required
Strong presentation and interpersonal skills with experience providing evidence based scientific and clinical information to HCPs
Knowledge of therapeutic treatment guidelines, clinical research processes, FDA regulations, and OIG guidelines
Excellent interpersonal communication and presentation skills are required
Must possess demonstrable effective leadership skills (by example and through accomplishments), and is able to step forward to handle challenges within scope of authority

Associate Scientific Director Resume Examples & Samples

An experienced CP lead that provides independent leadership on teams, overseeing, monitoring, or conducting clinical pharmacology programs for multiple compounds, including preparation of the Phase 1 clinical study and CP product development plans, and provides input on the integrated global development plan and strategy
Oversees preparation of PK/PD data analysis plans and provides input on statistical analysis plans (SAP) for Phase 1 clinical studies
Knowledgeable in the application of software used in advanced PK/PD data analyses and uses this technology within assigned programs
Oversees or independently performs advanced PK/PD data analyses and provides interpretation of PK/PD data and associated statistical analyses
Critically reviews and provides input on relevant sections of Phase 1 clinical study reports (CSR)
Provides technically sound CP contributions to key regulatory submission documents
Independently provides scientific review and provides input on clinical pharmacology regulatory documents and scientific white papers
Provides scientific and strategic leadership to technical discussions of a highly proprietary nature in response to queries from health care authorities
Represents Takeda at external meetings and conferences; establishes the reputation of Takeda with key opinion leaders, partners , and the public at large
When required participates in the review of new product opportunities, critically evaluating existing data and providing input regarding the advantages and development risks of each opportunity
Collaboratively interacts with scientists from other functional areas in PDD, as well as from other Takeda divisions, affiliates, and alliance partners
Mentors junior staff to ensure they value scientific excellence
In area of expertise serves as an internal clinical pharmacology expert with a high degree of accountability
Equivalent combinations of education and experience should be noted.)
Relevant Doctorate degree plus significant experience in a Clinical Pharmacology, Pharmacokinetics or other relevant position. Exceptional, highly experienced individuals with a Master’s degree
Educational degree is expected in a relevant scientific area, e.g., Pharmacology, Pharmacokinetics, Pharmacodynamics, Drug Metabolism, Pharmacy, etc
Significant drug development experience from a clinical pharmacology perspective
In depth, expert knowledge and application of advanced pharmacokinetics and pharmacodynamics as well as interpretation of complex data and statistical analyses
Must have scientific and technical expertise as evidenced by publications, patents, awards/honors and credibility at professional societies
Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, bioanalytical chemistry, and pharmaceutical science
Thorough understanding of drug development and global regulatory requirements
Excellent oral and written communication skills that includes skill in writing, reviewing, and editing scientific documents
Ability to effectively influence colleagues and multi-disciplinary project teams

Associate Scientific Director Resume Examples & Samples

Lead discovery activities for one or more project to develop candidate live-attenuated, inactivated, or recombinant vaccines through pre-clinical evaluation
Effectively manage a team of Ph.D. scientists and research associates, including promoting a culture of team accomplishment and providing career development
Design program and lead team to execute complex vaccine development activities in support of regulatory filings for new vaccine candidates or those already in clinical development, including
Lab-scale processes for seed virus generation and antigen production
Analytical method development to quantitate potency and characterize vaccine components
Immunogenicity and efficacy models and immune assays to quantify immune responses in pre-clinical studies
Novel immunogenicity and virology assays for exploratory clinical endpoints
Analyze, interpret and summarize complex data and contribute to project decisions
Propose, establish and lead collaborative projects with academic and corporate collaborators or CROs
In collaboration with clinical development, design and execute R&D studies to characterize human clinical immune responses to candidate vaccines in development
Collaborate with process development and CMC in the transfer of analytical methods and vaccine candidates
Present project plans, status and results in internal and external meetings and publications
Ph.D. in a scientific discipline with a minimum of 14 years vaccine development experience , MS in a scientific discipline with a minimum of 16 years vaccine development experience, or a BS in a scientific discipline with a minimum of 18 years vaccine development experience
Proven ability to design and develop viral vaccines, including scientific accomplishment in virology, molecular biology, immunology or related field
Scientific management experience, including demonstrated experience managing laboratory personnel in a team environment and a working knowledge of scientific project management
Significant industry experience and working knowledge of GLP practices
Compliance with Takeda safety practices and standard operating procedures

Associate Director, Scientific Computing Resume Examples & Samples

Lead and develop a diverse team of experts, including contractors and direct reports, in bioinformatics, high performance computing, cloud computing, image analysis, and related scientific computing disciplines
Define vision and implement strategy for scientific computing team, systems and services to meet and anticipate the needs of computational scientists across multiple R&D disciplines and manage daily service across a continuum from “self-serve” to “dedicated support”
Develop and maintain relationships with key partners and stakeholders in IT and R&D
Lead continuous innovation and change in both internal and external environments to support agile and responsive services and leverage technological advances
Champion a team culture of responsiveness, agility and scientific excellence
Stay abreast of the latest technology and methods for scientific computing and high performance computing
Lead the evaluation and selection vendors, services, collaborators and platforms in partnership with Enterprise Architecture, Solutions Design, and R&D teams
Communicate internally and externally about the Scientific Computing Services and Technologies
Negotiate and manage a software and contractor budget that will vary annually

Associate Scientific Director Resume Examples & Samples

In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, assists and supports for assigned products/projects
May assist with the scientific review, development execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
May be responsible for opinion leader development within the therapeutic area
May assist in scientific 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 or medical literature and acts as a therapeutic area resource
Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements
May assist in the development of scientifically accurate marketing materials, advisories, and symposia
Initiate research projects and drive them to completion, resulting in high quality publications

Associate Scientific Director, GI DDU Resume Examples & Samples

A scientific research leader within the GI Drug Discovery Unit, working within a highly matrixed & virtual environment, contributes to building a robust preclinical and early clinical pipeline in gastroenterological diseases
Plays a key role in translational research activities in partnership with Translational Research & Early Clinical research team and expert external groups
Identifies, establishes and ensures the success of key external collaborations targeting and developing novel therapeutic approaches to GI disorders, focused on stem cell therapy approaches to enteric neuropathies, inflammatory disorders and liver diseases
Builds relationships & collaborates with scientific leaders, KOLs, academic partners, CROs and biotech companies and is seen as an international subject matter expert in GI research and therapeutics
Responsible for oversight of local external partnerships (CRO, academic labs, etc.) to ensure milestones, deliverables are met according to timelines and expectations of quality
Identified as a Global Takeda thought leader in GI disease research and provides subject-matter expertise, with an emphasis on GI motility disorders
Represents Takeda and is responsible for creating a presence in the local GI and related scientific community through scientific meetings, advisory boards, online research communities, etc
Keeps up with the up-to-date scientific advancement (e.g. competitive situation, new technology, new research portfolio, and new partnership) and is well informed about current regulatory (FDA, EMA, etc.) requirements and trends
Has an advanced degree in health or life sciences (e.g., Ph.D., M.D., D.V.M.) with proven GI basic / translational research experience and accomplishment
Has expertise in GI motility disorders and underlying enteric neuropathies
Demonstrated expertise in innovative research into stem cell approaches to the treatment of motility disorders and other GI diseases
Demonstrates good knowledge of translational research, through to early clinical research (Proof of Concept)
Capable of leading a matrix team comprised of scientists from within Takeda as well as external collaborators

Associate Scientific Director Resume Examples & Samples

Provides representation and leadership on strategic and operational cross-functional teams
Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with QS and DMPK. Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans
Works closely with colleagues in QS to ensure appropriate quantitative support for the program is achieved
Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis, resolution of internal decision points and external regulatory interactions
Responsible for clinical pharmacology summary documents (such as IB, CTA)
Performs PK/PD analyses or guides such analyses as appropriate
Maintains a high standard for good clinical practice, compliance and ethics
Represents Takeda QCP in meetings with regulatory agencies and Health Authorities
When required participates as a member of Business Development due diligence
Ph.D. or equivalent degree + 5-7 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience
Pharm.D. +7 years of clinical pharmacology, pharmacokinetic, pharmacometrics, or other relevant experience
M.S. +10 years of clinical pharmacology, pharmacokinetic, pharmacometrics, or other relevant experience
B.S. + 15 years of clinical pharmacology, pharmacokinetic, pharmacometrics, other relevant experience
Educational degree in a relevant scientific area, e.g., Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmacodynamics, Drug Metabolism, Pharmacy, or other related area
Demonstrated scientific and technical expertise through publications, patents, awards/honors or credibility at professional societies. Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, bioanalytical chemistry, and pharmaceutical science
Demonstrated experience with design and analysis of clinical pharmacology studies
Excellent understanding of and interests in PK/PD, modeling and simulation, and use of clinical biomarkers for decision making
Effective at building alliances across functions
Excellent interpersonal communication skills, able to drive global collaborations in cross-functional, multi-cultural organizations

Associate Scientific Director Resume Examples & Samples

Scientific management of the design, execution and analytical validation plan of immunohistochemistry assays for the evaluation of predictive and pharmacodynamic biomarkers in both human tissues and in vivo pharmacology models
Approve validation reports and technical reports for molecular pathology assays - Contribute to relevant regulatory documents when required
Approve assay transfer quality for assays transferred to external contract research organizations and companion diagnostic partners in support of clinical development and companion diagnostic development
Perform technical audits of contract laboratories, including companion diagnostic site laboratories, and report findings in the form of written reports
Provide scientific direction and expertise in the area of pathology for both non-clinical and clinical study experiments, including writing relevant sections of clinical trial protocols
Communicate pathology results in the form of written and oral reports and disseminate regular written project updates to line management and relevant compound development team members
Evaluate, interpret and report pathology based clinical study conclusions to Translational Research representatives, to clinical development teams and to physicians participating in clinical trials as appropriate
M.D., D.V.M., V.M.D. or equivalent with at least 3 years post graduate training in academia or industry is required
Oncology experience is required
Experience with immunohistochemistry assay validation is required
Board certification in Anatomic Pathology and/or Molecular Genetic Pathology is preferred
Familiarity with digital pathology imaging is preferredClinical Research MD

Associate Scientific Director Resume Examples & Samples

Collaborates with key stakeholders, including, but not limited to, Discovery, Translational Research, Clinical Research, Regulatory and Commercial teams to develop a diagnostic strategy to enable registration of a pharmaceutical asset
Interacts early with Discovery and Translational Research to understand the predictive hypotheses to be tested for specific programs. Collaborates with internal research capabilities to develop a predictive assay if not already available
Selects contract laboratory for testing predictive assays in early clinical development
Oversees assay transfer to contract laboratory and ensures proper assay validation by working with subject matter experts within the department
Collaborates with Translational Research and with Clinical Research to design studies to test the clinical utility of the companion diagnostic
Selects diagnostic partner to deliver potential companion diagnostic kit in time for pharmaceutical registration
Manages relationships with contract laboratories and companion diagnostic partners including ensuring in-stream data quality from partners
Works with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents (e.g. IDEs, PMAs, etc.) are delivered and communicates with regulatory authorities when required
Regularly communicates updates to, and seeks feedback from, Clinical Teams, Compound Development Teams, and other stakeholders where appropriate, surrounding progress of the companion diagnostic program
PhD degree with at least 6 years experience in drug development is required
Experience with IVD development is required
Assay development experience required
Oncology experience preferred
Up to 10% domestic and international travel is requiredR&D

Associate Scientific Director Resume Examples & Samples

Lead the development and implementation of high impact and strategically aligned training for field medical teams within oncology
Ensure training materials are accurate, consistent and relevant for MSL needs and updated as and when necessary, to ensure the most up to date disease area, AbbVie asset and competitor information is available
Work with the Global Medical Affairs team to facilitate the uploading, ongoing management and version control of training materials on the MSL SharePoint site
Generate core communication and engagement materials for use by MSLs when in the field. Similarly, work with the GMA team to facilitate the uploading, ongoing management and version control of core materials that are compatible with the technology platforms that will be utilized by the in-field teams
Develop and execute, in partnership with the Global Therapeutic Area Lead and GMA Training Function, a training strategy for in-field medical personnel across the global organisation, within the assigned therapeutic area
Develop and maintain a comprehensive and well-structure training syllabus for the assigned therapeutic area and develop the requisite materials, to ensure the highest level of quality/content, which will positively impact disease area/product training
Develop and maintain innovative and impactful engagement/communication materials, that can be embedded in and exploit the full advantage of modern technology platforms (Veeva, iPad, Apps etc), to provide a differentiated and compelling scientific exchange experience for external customers
Ensure the seamless and accurate transfer of training and engagement materials to the requisite technology platforms, to ensure a comprehensive repository of training materials in SharePoint and engagement materials in Veeva/iPad
Lead the hosting of training initiatives (disease area, AbbVie assets, competitor data, engagement materials) on a consistent and periodic basis, both through face-to-face and web-based platforms, for field medical teams globally
Deliver training (content) on QPP18 Policy and In Field Teams (IFT) ways of working
Deliver training (content) on communication skills (eg: Medical Challenger)
Work with GMA Training Function to ensure the seamless roll-out (execution and content) of training initiatives, to deliver the highest standards of training that positively impact Field personnel globally
Develop the global communication plan and identification of supporting communication needs to optimise field medical communications
Ensure slide repositories are routinely updated and aligned with strategically relevant data as it becomes available
Oversee integration of field scientific intelligence as it is reported by field Medical staff
Oversee the distillation, organisation and high-level analysis of customer insights prior to dissemination to internal stakeholders
Lead the Academy for knowledge identification and dissemination for the Therapeutic Area, by reviewing and communicating key medical publications, clinical trials, competitor activities and serving as the therapeutic knowledge integration interface with the Knowledge Management function with GMA

Associate Scientific Director Resume Examples & Samples

Knowledge of GLPs and Health Authority regulations and guidelines for the development of biologics (e.g. ICH, FDA, EMEA, PMDA) is required
Experience in the design and execution of the nonclinical safety assessment strategy for biologic therapeutics is required
Prior experience serving as a Study Director and/or Study Monitor for nonclinical safety studies of biopharmaceuticals is preferred

Associate Scientific Director Resume Examples & Samples

With appropriate supervision, manages the design and implementation of study protocols for a clinical development 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
Has responsibility for review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables
Contributes to design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents
May be asked to contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members
Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies
Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research

Associate Director, Scientific Computing Resume Examples & Samples

Lead a small team of Scientific Computing engineers to prototype and execute scientific software development projects against needs and requirements comprising world-class data processing, QC and management platforms such as the NGS data generation and processing pipeline
Operationalize development projects into production quality tools in the existing research compute ecosystem for use by scientists
Work closely with scientists to understand scientific challenges, data needs, business needs, technology and software requirements and in turn communicate internally and externally about Scientific Computing
Define and develop a strategy for the systems and services that meet the needs of stakeholders and manage daily service across a continuum from “self-serve” to “dedicated support”
Develop relationships with key stakeholders and leaders across R&D to build a portfolio of services
Stay up-to-date and be familiar with new high performance computing technologies and anticipate and exploit use of new technologies that impact decision making in drug discovery
Lead evaluation, selection of, and work with outside vendors to design and implement solutions, as well as integrate them into internal pipelines
Work closely with IT to maintain Biogen's quality and scale of compute and storage infrastructure
Foster and commit to a team culture of continuous improvement, responsiveness, agility and technical excellence
LI-RD2
Relevant experience in creating and applying technologies to solve computationally intensive and data intensive in any of the following: bioinformatics, medical informatics, clinical informatics, distributed and high performance computing, large scale data transfer, data visualization
Excellent communications skills and experience leading a team and working as a member of a team in a matrix environment
Extensive knowledge of large scale biological data and methods of management, e.g. RNA-Seq, DNA-Seq, semantic data, imaging, data aggregation, data-marting, data virtualization, relational databases, object stores, column stores, triple stores, graph stores, document stores, storage resource broker/SRB, iRODs
Experience with high performance computing and storage such as distributed computing systems (e.g. SGE, LSF, PBS, Hadoop, Opengrid, Spark), cloud computing (e.g. AWS, Google Cloud), vendor platforms (e.g. EMC)

Associate Scientific Director Resume Examples & Samples

Edit (clinical edit and line edit) content received from faculty/authors and medical writers for clarity, medical/scientific accuracy, alignment with learning objectives and other specifications from the grant proposal, and consistency with the target learner audience
Write editor’s notes and introductions for, and summary statements of, content received from faculty/authors and medical writers
Develop PowerPoint presentations for multimedia programs
Deliver assignments according to specified timelines and quality standards; and
Function independently within 3 months in all of the above
Maintain up-to-date knowledge of important clinical issues and advancements, approved therapeutic drugs and regimens, major publications, and clinical practice guidelines, in the fields of gastroenterology, infectious diseases, hematology/oncology, and pulmonary medicine
Acquire up-to-date knowledge of other therapeutic area(s) within specified timeframes, as needed
Interpret quantitative and qualitative research findings
Degree in clinical or scientific field, or medical or scientific writing
Minimum of 3 years’ experience as a medical writer and/or editor in a medical education company, medical communications company, professional medical publisher, academic institution, and/or medical society or pharmaceutical company
Knowledge of and ability to apply ACCME standards to content development
Online publishing experience preferred
Medical Writer Certified (MWC™) credential preferred
Editorial skills: developmental, substantive/structural, stylistic, rewriting
Advanced skill level in Microsoft Word and Outlook
Advanced skill level in PowerPoint
Basic skill level in Excel and Adobe Acrobat
Basic skill level in ReadCube and EndNote
Ability to work effectively and efficiently on shared networks/corporate applications (Workfront, SharePoint, Sales Force, Lync, Box)
Organizational skills necessary for effective time management and multitasking
Ability to work in cross-functional internal teams including outcomes, product development, production, studio

Associate Scientific Director Resume Examples & Samples

The Assistant or Associate Scientific Director, USMA, Early Pipeline & CDx works with the Scientific Director, USMA Oncology Research & Pipeline to carry out the following responsibilities
Establish and maintain internal and external relationships to facilitate Medical activities
Apply experience and expertise of Oncology technical, scientific and medical knowledge to Medical plans and tactics
Keeps abreast of technical, scientific and medical information through attendance of selected Scientific Congresses, literature and other sources of relevant information and acts as a therapeutic area expert in biomarkers, companion diagnostics and early Oncology pipeline
Promptly alerts Oncology USMA team, ADTs, Field Medical and other relevant staff of the most critical new information
Provides scientific/ medical education to TA staff, Medical Field staff, ADT and CST team members related to therapeutic area, biomarker, diagnostic and disease-specific information
In cooperation with cross-functional and in-function colleagues, provides leadership, oversight and support for assigned initiatives with a clear plan and drives execution of the right tactics to completion on time
Maintains a repository for non-published information such as posters, slides, congress debriefs, trip reports, and analyses as a resource for the TA
Works interactively with disease experts, scientists, pathologists, project teams in both Discovery and Pipeline Development, as well as experts external to AbbVie, to identify relevant questions and topics to be addressed in Field Medical, Congress Booth or other relevant materials
Responsible for understanding regulatory and OEC requirements and works to continuously achieve the highest levels of compliance
Assists Scientific Director, USMA Research & Pipeline to establish and implement a CDx framework and operating model in conjunction with the AbbVie Oncology Therapeutic Area Strategy Council (TASC)
No direct supervisory responsibly. Effectively guide scientific personnel within the matrixed Oncology Therapeutic Area
The incumbent should have a strong understanding of Medical Affairs and Oncology with recent pharmaceutical industry experience in the field. The incumbent should have extensive experience interacting internally and externally to support Oncology TA strategy. Past experience with CDx development and Immuno-Oncology is desired. The incumbent should be highly organized and demonstrate a passion for driving to achieve objectives and goals. Excellent oral and written communication skills are essential
Advanced education (e.g. M.D., Ph.D., PharmD., PA, NP) highly preferred. Residence and/ or postdoc or industry experience in Oncology also highly preferred to ensure that incumbent has necessary theoretical and practical knowledge to do the job
At least 5 years’ experience in the pharmaceutical or diagnostic industry with professional responsibility driving completion of strategic initiatives and tactical plans with a collaborative approach. Demonstrated success to leading cross-functional teams to achieve business strategic goals
This position will be hired as an Assistant or Associate Scientific Director based on the candidate's experience

Associate Scientific Director Resume Examples & Samples

Develop original clinical content (monographs, newsletters, slide decks, etc) across multiple delivery platforms―print, live, and digital (web, tablet, and mobile)―in accordance with established budgets, timelines, and strategic objectives
Re-purpose client-supplied materials for use in custom promotional and educational programs for healthcare professionals
Assess clinical accuracy of all content through careful review of source materials, including medical and scientific journals
Take the lead on calls with clients to kick-off projects and review project status
Prepare for and participate in medical/legal/regulatory reviews as needed
Identify thought leaders, authors, and other expert sources for custom projects and help maintain database of these contacts
Develop content for and participate in off-site programs (e.g., advisory boards, product theaters) outside of normal working hours on an as needed basis
Develop effective, collaborative working relationships with fellow employees, clients, faculty, and vendors
Experience in medical content development (monographs, newsletters, slide decks, etc) across multiple delivery platforms (print, digital, and live programs) within an organization serving pharmaceutical clients
Experience in, or ability to understand, multiple therapeutic areas and quickly come up to speed in new therapeutic areas
Experience in interpreting clinical data with an ability to communicate an understanding of that data both verbally and in writing
Experience in preparing for medical/legal/regulatory reviews, including document submission into multiple client-specific portals
Ability to work concurrently on several complex projects, meet aggressive deadlines, and adjust priorities rapidly as a situation demands
Careful attention to detail, especially with regard to the accuracy of data and other scientific content
Self-motivated, with the ability to work independently and within a team environment to move projects from inception to completion
Strong organizational, interpersonal, and verbal/written communication skills
An advanced degree in life science (MD, PhD, PharmD)

Associate Scientific Director Resume Examples & Samples

Develop brand or TA strategies with manager oversight
Develop external communication plans (e.g. Medical Education, Advisory Board, EE Engagement Plan, Conference plan) in line with a TA or brand plan. Execute elements of the communication or conference plan
Identify and summarize data that supports external communication tactics (e.g. DOF)
Manage the budget for assigned projects
Provide subject matter expertise to cross-functional teams
Contribute to the generation of externally focused scientific statements or communication messages
Contribute to the external customer Engagement Plan
Generate content for externally facing written communication (e.g. GMI letters, HCP directed promotional or educational materials)
Contribute to the design of data generation projects (e.g. clinical trials, RWE, MABI research) and execute safety appropriate for the project
Train non-field internal teams on label, clinical data and disease state (e.g. train MR team, commercial)
Bachelors degree in the sciences; advanced degree (e.g., MD, PharmD, PhD) strongly preferred
Strong desire to collaborate in a cross-functional setting and ability to build effective relationships
Ability to interact externally and internally to support global scientific and business strategy
Must possess excellent oral and written English communication skills