Executive Medical Director, Clinical Development Hematology
About The Position
The Executive Medical Director (EMD) provides medical leadership for multiple clinical development programs, generally overseeing two or more programs and guiding Medical Directors and Clinical Development Scientists. The role contributes to cross-asset and therapeutic-area strategy, regulatory strategy, and strategic decisions with senior teams. It may include direct or indirect managerial responsibilities and may involve specific business development efforts, such as due diligence, while maintaining close ties with Discovery and Research. This specialized role provides medical leadership to Program Teams across early- to late-stage drug development, from IND/CTA and first-in-human studies through proof of concept and end-of-Phase-2 and beyond. The EMD serves as a medical expert for study teams and may act as a clinical-trial medical monitor. Typically responsible for multiple programs in a therapeutic area, the EMD leads clinical development strategy and execution, manages product benefit-risk profiles, and represents Clinical Development internally and externally. The position offers scientific and commercial interaction and career advancement in rare disease. The role is generally conducted in an office environment and requires the ability, with or without accommodation, to use a computer; communicate by phone, video, and electronic messaging; solve problems and engage in analysis and dialogue; collaborate; and maintain general availability during standard business hours. The role expects at least three days per week in the office, with flexibility around that expectation.
Requirements
- M.D. or equivalent.
- At least 7 years of experience in clinical development; clinical research, global regulatory, and product development expertise.
- Experience preparing documents for and attending meetings with the FDA and other regulatory agencies.
- Experience designing and executing multinational clinical trials.
- Demonstrated ability to lead cross-functional teams in defining clinical strategy and clinical study design.
- Experience supporting business development activities.
- Ability to perform the stated office-based duties, with or without accommodation, including computer use, communication, problem solving, collaboration, and general availability during standard business hours.
Nice To Haves
- Clinical training is preferred.
- Advanced knowledge of the assigned therapy area and the ability to interpret, discuss, and represent trial- or program-level data.
- At least 7 years of industry experience in clinical development is preferred.
- A Ph.D. in a related discipline is desirable but not required.
Responsibilities
- Typically lead two program teams and drive successful execution of clinical studies, programs, and research strategies; define and manage product benefit-risk profiles.
- Represent Clinical Development on Global Program Teams and Global Medicine Teams, including presentations to management and review committees.
- Advance understanding of rare and orphan disease pathophysiology and therapy impact through scientific discourse and interpretation of data.
- Develop Medical Directors, Clinical Development Scientists, and/or fellows; lead and oversee programs and prepare and execute clinical development strategies and related documents.
- Provide scientific and medical consultation to R&D, commercial, translational medicine, and business development functions; lead or oversee clinical activities supporting due diligence.
- Represent Clinical Development to internal management and cross-functional teams, and to external academic, regulatory, and medical communities.
- Oversee cross-functional development of clinical components of clinical development plans and serve as Clinical Development input to Global Development Teams and study teams.
- Oversee writing of clinical sections of the CTD, white papers, expert opinion reports, regulatory responses, and other clinical development documents.
- Coordinate with Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology, and Medical Science on study design, execution, and interpretation of results.
- Serve as the medical expert on global product labeling teams.
- Monitor scientific, clinical, competitive, and regulatory developments that could affect development plans, including through conferences, competitive intelligence, and literature review.
- Write or contribute to white papers, expert opinion reports, and regulatory responses.
- Drive clinical support for business development activities, including due diligence and research collaborations.
- Evaluate disease and competitive-landscape information and synthesize findings for clinical development programs, asset plans, and therapeutic-area strategy.
- Determine appropriate experts for advisory boards.
- Work cross-functionally with colleagues in areas such as biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management.
- May supervise other medical monitors on individual studies.
Benefits
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
