Medical Director, Rare Autoimmune Nephrology

Summary

Join us at Biogen's West Coast Hub as we seek a highly motivated and experienced Medical Director to support development activities for our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease.

Responsibilities

• Support the design and execution of clinical development plans for HI-Bio's programs within rare autoimmune and nephrology therapeutic areas
• 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 HI-Bio externally at scientific conferences, investor meetings, and other industry events