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Medical Director, Clinical Development, Immunology
About this Role
The Medical Director, Clinical Development - Immunology, sits within Biogen's Multiple Sclerosis (MS) and immunology Development Unit (MS I DU). The Medical Director will lead the development of BIIB059 for one indication in immunology (currently targeting Lupus or other autoimmune diseases). The Medical Director will work cross-functionally and closely with the MS & Immunology clinical teams in the MSIDU and the R&D Project Leader. This position will report to a Senior Medical Director and 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 potentially. In addition, the Medical Director will serve as a contact for business development needs / external innovation activities.
What You'll Do:
Lead the execution of late-stage development plans for Lupus
Contribute to the strategic roadmap in Immunology
Provide direct leadership within the Lupus team; work with a diverse team to support Lupus and other potential new molecules and/or indications in immunology; Build relationships across the MS I DU 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 to develop, execute, and advance a strategic and successful development program. You have experience managing high-performing teams and providing the necessary guidance and mentoring for all to reach their goals.
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
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
All your information will be kept confidential according to EEO guidelines.