Executive Medical Director, Clinical Development Hematology

Alexion•Boston, MA

14h•Hybrid

About The Position

The Executive Medical Director (EMD), Clinical Development Hematology, provides senior medical leadership for multiple clinical development programs, typically overseeing two or more programs from early through later stages of development. The role guides and mentors Medical Directors and Clinical Development Scientists, contributes to therapeutic-area and regulatory strategies, and participates in cross-asset strategic teams and senior decision-making forums. The position reports under the supervision of a VP Clinical Development TA Head and may have direct or indirect managerial responsibilities for medical development staff. The EMD provides medical expertise to program and clinical study teams, may serve as a medical monitor, and leads clinical development strategy and execution. Responsibilities span preparation and oversight of clinical development plans, study design and execution, interpretation of data, regulatory documents and interactions, product labeling, and cross-functional coordination. The role also supports business development and due diligence, maintains close connections with Discovery and Research, and represents Clinical Development to internal and external stakeholders. The position offers scientific and commercial interactions and career advancement in rare disease. The role is hybrid, with an expectation to work in the office at least three days per week. Duties are generally conducted in an office environment, and employees must be able to perform computer-based work, communicate by phone, video, and electronic messaging, collaborate, solve problems, and maintain general availability during standard business hours, with or without accommodation.

Requirements

M.D. or equivalent; clinical training is preferred.
At least 7 years of experience in clinical development; expertise in clinical research, global regulatory matters, and product development.
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.

Nice To Haves

Advanced knowledge of the assigned therapeutic area and ability to interpret, discuss, and represent trial- or program-level data.
At least 7 years of industry experience in clinical development.
Ph.D. in a related discipline.

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 the Global Program Team and Global Medicine Team, including presentations to management and review committees.
Advance understanding of therapies and rare- or orphan-disease pathophysiology through scientific discussion and data interpretation.
Foster the development of Medical Directors, Clinical Development Scientists, and/or fellows.
Lead and oversee two programs and prepare and execute clinical development strategies and related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
Provide scientific and medical consultation to R&D, commercial, translational, medicine, and business development functions, and lead or oversee clinical activities supporting due diligence.
Represent Alexion Clinical Development to internal R&D management, cross-functional development teams, and executive committees, and to external academic, regulatory, and medical communities.
Oversee cross-functional teams developing the clinical components of the clinical development plan.
Provide clinical input to Global Development Teams and subteams and act as a medical expert for clinical study teams.
Oversee preparation of clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses.
Coordinate communications and planning among medical functions, including Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology, and Medical Science, for study design, execution, and interpretation of results.
Serve as the medical expert on the global product labeling team.
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.
Critically evaluate disease-area information and the competitive landscape, and synthesize findings for clinical development programs, asset plans, and therapeutic-area strategy.
Determine appropriate advisory-board experts.
Work with cross-functional colleagues, including biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management teams.
May supervise other medical monitors on individual studies.
May contribute to regulatory strategy, therapeutic-area and functional strategies, and discrete business development efforts such as target due diligence.