Job Description
About This Role
HI-Bio, Inc., a Biogen company, is 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 and as a key member of the clinical development team, you will support 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.
What You Will Do
- 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 HI-Bio externally at scientific conferences, investor meetings, and other industry events
This position is open to US-remote talent with a strong preference for West Coast (PST) candidates able to travel into our South San Francisco, CA office.
Who You Are
You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.
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