Medical Director, Transplant Lead

1 week ago


San Francisco, California, United States Biogen Full time
About This Role

HI-Bio, a Biogen company, is seeking a seasoned Medical Director to support the development of our immunology clinical programs, focusing on immunological complications of transplantation. As a key member of the clinical development team, you will collaborate with Clinical Operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing teams to drive the successful execution of clinical development plans and regulatory filings.

Key Responsibilities
  • Support the design and execution of clinical development plans for HI-Bio's transplant programs, 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, establish and maintain relationships with key opinion leaders and clinical investigators in the transplantation field, and 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.
  • Present relevant clinical data to internal stakeholders and represent HI-Bio externally at scientific conferences, investor meetings, and other industry events.
About You

You have significant experience in clinical trials, strong communication and presentation skills, and a passion for improving the lives of patients. You are curious, creative, and collaborative, with a deep understanding of clinical trial design and execution, regulatory requirements for drug development, and biomarker-based approaches.

Requirements
  • MD or equivalent degree, with board certification in nephrology, immunology, or a similar field.
  • Minimum of 3+ years of clinical development experience in the pharmaceutical or biotechnology industry, with a track record of successful drug development.
  • Experience in late-stage drug development, with a preference for experience in transplant, nephrology, and/or immuno-inflammatory indications.
  • Strong knowledge of clinical trial design and execution, regulatory requirements for drug development, and biomarker-based approaches.
  • Ability to travel domestically and internationally, approximately 10-20% of the time.

HI-Bio, a Biogen company, offers a dynamic and inclusive work environment, opportunities for growth and development, and a competitive compensation package, including a base salary range of $192,000 - $288,000, eligibility for participation in Biogen's LTI grants and other incentive programs, and a comprehensive benefits package, including medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.



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