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Biogen Medical Director, Clinical Development, Immunology in Cambridge, Massachusetts

/ABOUT THIS ROLE/ The new Medical Director, Clinical Development, Immunology sits within Biogen’s Neurorepair Development Unit (NRDU). The Medical Director will lead the development for one or more programs in immunology; currently targeting lupus or other autoimmune diseases. The Medical Director will work cross-functionally and in close collaboration with the Multiple Sclerosis & Immunology clinical teams in the NRDU. This position will report to a Senior Medical Director and will provide clinical science support for assigned programs. The Medical Director will have direct responsibility for advancing high priority clinical programs in all stages of development. The initial responsibilities will be leading the articulation of the clinical development plan, including: regulatory strategy, scientific analysis, and expanding the clinical development plan to include other indications. In addition, the Medical Director may serve as a contact for business development needs / external innovation activities. /Responsibilities/ * Lead the execution of late stage development plans in Lupus; Contribute to the strategic roadmap in Immunology * Provide direct leadership within Lupus team; Build a team of clinical scientist and physicians to support Lupus and other potential new molecules and/or indications; Build relationships across the NRDU and Biogen * Represent the Lupus team at product team meetings and R&D governance committees * Work closely with various health authorities; acting as the main point of contact both internally & externally * Serve as the primary clinical development reviewer on protocols, IBs, CSR and other regulatory documents * Ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice (GCP) /Who You Are/ You are a proven leader within the Clinical Development, Immunology space and strive on developing, executing and advancing a strategic and successful development program. You have experience managing high performing teams; providing the necessary guidance and mentoring for all to reach their goals. #LI-NM1 MD, MD/PhD or PhD is required * Five (5) plus years of pharmaceutical industry experience in clinical drug development is required; preferably in Immunology, Dermatology, and/or Rheumatology * Relevant regulatory experience, including: development of regulatory documents and working with various health authorities; ability to understand and effectively communicate scientific, medical and regulatory information * Demonstrated leadership and team building skills; as well as the ability to perform effectively in a dynamic environment * Ability to anticipate and adapt to change while maintaining the momentum for the strategy plan; ability to work independently, complete tasks in a timely manner and function in a fast paced, high pressure environment * Demonstrated strategic and critical thinking; strong ability to conduct medical and scientific analysis * Excellent written and oral communication skills The new Medical Director, Clinical Development, Immunology sits within Biogen’s Neurorepair Development Unit (NRDU). The Medical Director will lead the development for one or more programs in immunology; currently targeting lupus or other autoimmune diseases. The Medical Director will work cross-functionally and in close collaboration with the Multiple Sclerosis & Immunology clinical teams in the NRDU. This position will report to a Senior Medical Director and will provide clinical science support for assigned programs. The Medical Director will have direct responsibility for advancing high priority clinical programs in all stages of development.

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