Executive Medical Director, Medical Affairs - Solid Tumors

Role Summary

The Executive Medical Director provides specialist medical and scientific strategic and operational input into core medical affairs in the designated therapeutic area, with a focus on ovarian cancer. The role includes HCP interactions, generation of clinical data, educational initiatives, and safety surveillance, and involves partnering with commercial teams to shape brand strategies and market access. It also entails delivering scientific presentations, maintaining relationships with key opinion leaders, and developing medical affairs strategies and training for assigned products.

Responsibilities

• Establishes and approves scientific methods for hypotheses, rationale, design of study protocols and their reports across different products.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Qualifications

• 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.)
• Minimum of 5 years of clinical trial experience in the biotech/pharmaceutical industry or academia or equivalent. 7+ years of experience is preferred.
• Proven leadership skills in a cross-functional team environment. People management experience preferred.
• Ability to run a clinical program or medical affairs team(s) independently with little supervision.
• Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols.
• Expert knowledge in a relevant therapeutic specialty. Experience in a senior role in a TA preferred.
• Must have an understanding of the Pharmacovigilance practices for Clinical Development programs.
• 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.