Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Executive Medical DirectorLocation: Barcelona, Spain
Reports To: Vice President, Clinical Development, Neurology, Alexion
This is what you will do:The Executive Medical Director is generally 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. Manages the 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. Support development of regulatory strategy and therapeutic area strategy.
You will be responsible for:Typically lead 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.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 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 diligence.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 between 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 contributing to white papers, expert opinion reports, and regulatory responses.Driving clinical support of 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 and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.Determining 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: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.
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