Medical Director, Rare Autoimmune Nephrology

Company Description

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission: Caring Deeply, Achieving Excellence, Changing Lives. 

Our team in 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

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 Hybrid based and travel to our San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate we may open to remote hires.

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.

Qualifications

Required Skills

• MD or equivalent degree, with board certification in nephrology, immunology, or 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, wit