Executive Medical Director, Clinical Development, Hematology

Location: Boston, MA

About the role

The Executive Medical Director (EMD) oversees 2 or more programs, providing leadership, guidance, and mentoring to Medical Directors and Clinical Development Scientists. This role involves serving on cross-asset strategic teams (e.g., disease strategy teams) and contributing to strategic decisions at the Therapeutic Area (TA) Strategy Team and Global Medicine Team meetings. The EMD may have managerial responsibilities over Senior Directors and Medical Directors in Clinical Development and may support or oversee other Medical Directors or Clinical Development Scientists indirectly.

The EMD provides medical leadership and input to Program Teams during early to late-stage drug development, from IND/CTA and First-in-Human studies through Proof-of-Concept and End-of-Phase-2 stages and beyond. The role serves as a medical expert for study teams and may act as the medical monitor for clinical trials. The EMD is responsible for multiple clinical development programs in a therapeutic area, spanning IND to POC/Phase 2/3, under the supervision of a VP Clinical Development TA Head. This position may also involve discrete business development efforts, such as due diligence on specific targets, and maintaining close ties with Discovery and Research organizations. The role offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.

Responsibilities

• Lead 2 program teams and drive the successful execution of clinical studies, programs, and research strategies; define and manage the benefit-to-risk profile of products.
• Represent Clinical Development on the Global Program Team (GPT) and Global Medicine Team in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee).
• Advance understanding of the impact of therapies on the pathophysiology of rare and orphan diseases through scientific discourse and data interpretation.
• Foster the development of Medical Directors, Clinical Development Scientists, and/or fellows.
• Lead and oversee the preparation and execution of 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 input to other R&D, commercial, translational, medical, and business development functions; lead or oversee clinical activities to support due diligence.
• Represent Alexion Clinical Development to internal (R&D management, cross-functional development teams, executive committee) and external (academic, regulatory, and medical) communities.
• Oversee a cross-functional team developing the clinical components of the Clinical Development Plan (CDP).
• Serve as the clinical input to Global Development Teams/Subteams and as the medical expert for clinical study teams.
• Oversee the writing of clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses.
• Liaise internally with other members of the CDP to drive program strategy and clinical development plans.
• Coordinate communications and planning between medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology, and Medical Science) as they relate to clinical development study design, execution, and interpretation of results.
• Serve as the medical expert on the global product labeling team.
• Drive awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Write or contribute to white papers, expert opinion reports, and regulatory responses.
• Drive clinical support for business development activities, such as due diligence and research collaborations.
• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape; synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy.
• Determine appropriate advisory board experts.
• Work as part of a cross-functional team with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management.
• May supervise other medical monitors on individual studies.

Requirements

• M.D. or equivalent in Hematology.
• 7+ years of experience in clinical development, clinical research, global regulatory, and product development expertise.
• Experience preparing documents and attending regulatory meetings with the FDA and other regulatory agencies.
• Experience designing and executing multinational clinical trials.
• Demonstrated ability to lead cross-functional teams to define clinical strategy and clinical study design.
• Experience supporting business development activities.
• PhD in a related discipline is desirable but not required.

The duties of this role are generally conducted in an office environment. Employees must be able, with or without accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.

Skills

• Advanced knowledge of the assigned therapy area is preferred, with the capability to interpret, discuss, and represent trial or program-level data.
• 7+ years of experience in industry clinical development is preferred.