Medical Director, Clinical Development, Rare Autoimmune Nephrology

at  Biogen

Company Description
Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
Job Description
We are seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease. Reporting directly to the Clinical Development Lead, the MD is a key member of the clinical development team, supporting the development of our novel therapeutic candidates in late-stage studies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations, gaining comprehensive knowledge of the literature related to the product(s) in development, supporting Regulatory interactions, and supporting Medical Affairs and Commercial colleagues.
As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings.

Support the design and execution of clinical development plans for HI-Bio’s programs within rare autoimmune and nephrology therapeutic areas, ensuring alignment with strategic objectives and timelines
Provide medical and scientific oversight for clinical trials, including protocol development, study monitoring, data review, and analysis
Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
Draft and coordinate completion of clinical study reports
Prepare responses to questions from Ethics Committees and Health Authorities
Support integrated document development for marketing authorization filing
Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
Support preparation for FDA Advisory Committee and EU Oral Explanation
Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, and others
Establish and maintain relationships with key opinion leaders and clinical investigators in the nephroimmunology field and disease areas related to clinical development programs
Ensure compliance with regulatory requirements and guidelines
Collaborate with cross-functional teams
Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
Represent externally at scientific conferences, investor meetings, and other industry events