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Biogen Medical Director, Clinical Development, Alzheimer's in Cambridge, Massachusetts
The position of Medical Director, Clinical Development, Alzheimer’s Disease sits within the Neurodegenerative Development Unit and will support our late stage clinical development programs focused in Alzheimer’s & Dementia. The ideal candidate will have experience supporting drug development program, interactions with investigators/regulators and is enthusiastic about applying their knowledge to the cause of patients around the globe who suffer from Alzheimer’s Disease. The individual who assumes this highly visible position will interact both with cross-functional teams within Biogen and with external stakeholders. The individual will be a self-starter with excellent management and leadership capabilities who is seeking to be part of an innovative team. This position will serve as a key liaison between company and clinical investigators and establish credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners. The successful candidate will be ready for a career defining experience and have the passion to drive multiple programs for a serious debilitating disease to the final approval. Responsibilities, including but not limited to: * Follow important developments and relevant trends in the scientific literature and develop/maintain contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development of study and overall program. * Collaborate closely with regulatory team in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs. * Author and review written materials and provide editorial comments for clinical study reports and manuscripts. * Participate in the planning, writing, and review of Clinical Study Reports, regulatory updates, and submissions. * Ensure that operational activities are conducted in compliance with all pertinent regulatory or statutory requirements and in accordance with the scientific standards, ethical and professional values, management philosophy, and established priorities, policies, and practices of the Company. * Lead the disclosure of scientific content for the preparation of summarization of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling. * Manage direct reports * Must have the ability to travel for site visits, scientific meetings and other business needs Who You Are You are a proven leader within the Clinical Development, Neurodegenerative space and strive on developing, executing and advancing a strategic and successful development program. You have experience working with high performing teams; providing the necessary guidance and mentoring for all to reach their goals. #LI-NM1 * MD, MD/PhD or PhD degree is required. 5+ years of clinical and managerial experience in clinical drug development, ideally within neuroscience, rare disease or orphan indications. * Demonstrated strategic and critical thinking. Technical (Medical and Scientific) experience evaluating targets/agents for in licensing or internal development desirable. * Excellent interpersonal and public speaking skills are required for this high visibility position * Demonstrated ability to work in a matrix environment with cross-functional teams. The position of Medical Director, Clinical Development, Alzheimer’s Disease sits within the Neurodegenerative Development Unit and will support our late stage clinical development programs focused in Alzheimer’s & Dementia.