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 immunological complications of transplantation. 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. You 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 the transplantation therapeutic area, 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 transplantation 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

Present relevant clinical data to internal stakeholders

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.