Executive Medical Director, Clinical Development, Hematology, Nephrology, & Transplant, Cell Therapy

Executive Medical Director

General Description of the Role

The Executive Medical Director (EMD) role is generally assigned to be responsible for overseeing 2 or more programs, providing oversight/guidance/mentoring to the Medical Directors and Clinical Development Scientists on the teams, serving on cross-asset strategic teams (e.g., disease strategy team) and providing input to strategic decisions at the TA Strategy Team and Global Medicine Team meetings.

Generally, the role may include managerial responsibilities over Senior Director, Medical Director Clinical Development directly and may support / oversee other Medical Directors/Clinical Development Scientists that report indirectly to the Executive Medical Director. The EMD may support development of regulatory strategy, therapeutic area and other functional strategies.

Specifics of the specialized role

The EMD is a specialized role and is specifically designated to provide medical leadership and input to Program Teams during the early to late stage of drug development (i.e., transitioning molecule through IND/CTA and First-in-Human study stage to Proof-of-Concept and End-of-Phase-2 stage and beyond). The incumbent will serve as one of the medical experts for the study team(s) and may serve as the medical monitor for clinical trials as necessary.

In line with its seniority, the EMD is typically 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. In addition, she/he may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target) and keep close ties with the Discovery and Research organizations.

This position offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.

You will be responsible for:

• Typically leading 2 program teams and drive the successful execution of clinical studies / programs / research strategies; define and manage the benefit to risk profile of our products
• Representing 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 our therapies have on the pathophysiology of rare and orphan diseases through scientific discourse and interpretation of data
• Fostering development of Medical Directors and CDS and/or fellows. Lead and oversee 2 programs and the preparation and execution of a clinical development strategy and related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Providing scientific and medical input (consultative services) to other R&D, commercial, translational, medicine and business development functions and leads and or oversees clinical activities to support due diligences
• Representing Alexion Clinical Development to internal (R&D management, cross functional development teams and executive committee) and external (academic, regulatory, and medical) communities.
• Overseeing a cross functional team which develops the clinical components of the CDP. Serve as the Clinical input to Global Development Team / Subteams and medical expert for the clinical study team. Oversees the writing of the clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses
• Liaising internally with other members of the CDP to drive program strategy and CDPs. Coordinate communications and planning bet medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) as it relates to clinical development study design, execution and interpretation of results. Serves as the medical expert on the global product labeling team
• Driving 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
• Writing or contribute to white papers, expert opinion reports, and regulatory responses
• Driving clinical support of business development activities, such as due diligence and research collaborations
• Critically evaluating available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
• Determine appropriate advisory boards experts
• Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
• May supervise other medical monitors on individual studies

You will need to have:

• Required: M.D. or equivalent with experience in nephrology, preferably with clinical training experience
• 7+ years of experience in clinical development; clinical research, global regulatory, and product development expertise
• Has prepared documents and attended regulatory meetings with FDA and other regulatory agencies
• Experience designing and executing multinational clinical trials required
• Demonstrated ability to lead cross-functional teams to define clinical strategy and clinical study design
• Experience supporting business development activities
• PhD in related discipline desirable, but not required
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an 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; maintain general availability during standard business hours.

We would prefer for you to have:

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