The Senior Medical Director provides specialist medical/scientific strategic and operational input into core medical affairs activities within Solid Tumor portfolio. This will include healthcare professional/provider interactions; generation of clinical and scientific data; educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provides scientific and technical support for assigned products, provide relevant input to clinical development teams early and late stage on CDP; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in relevant Brand Teams and helps develop medical affairs strategies for assigned products. Develops innovative research concepts for clinical data generation; provide relevant scientific and technical training.
1. Establishes and approves scientific methods for hypotheses, rationale, design of affiliate/Area protocols and their reports across different products.
2. Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
3. 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.
4. All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.
5. Responsible for externally sponsored studies strategy development, for review and recommendations for approval.
6. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development. Identifies training needs.
7. Interacts 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.
8. Oversees scientific/medical education of investigators, clinical monitors, and 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.
9. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
10. Assists with the scientific review, development, approval, execution and communication of affiliate/area 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.
11. 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.
1. Proven leadership skills in a cross-functional team environment. People management experience preferred.
2. Ability to run a clinical program or medical affairs team(s) independently with little supervision.
3. Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols.
4. Expert knowledge in a relevant therapeutic specialty. Experience in a senior role in a TA preferred.
5. Must have an understanding of the Pharmacovigilance practices for Clinical Development programs.
6. 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 requirements. Must possess excellent oral and written English communication skills. Ability to interact externally and internally to support business strategy. International experience is a plus.
Senior Medical Director
1. Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred. National license to practice medicine preferred)
2. 7+ years of experience in the pharmaceutical industry or equivalent.
3. Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent., with Global Medical Affairs experience highly preferred.
Senior Scientific Director
Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
15+ years of experience in the pharmaceutical industry or equivalent.
Minimum of 10 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent, with Global Medical Affairs experience highly preferred.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.