Medical Director, Rare Autoimmune Nephrology
- Full-time
- Region: US
- Department: Research & Development
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. 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.
About This Role
HI-Bio, Inc. is seeking a highly motivated and experienced Medical Director (MD) to support development activities for 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, 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.
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.
- Provide medical and scientific oversight for clinical trials, including protocol development and study monitoring.
- 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 results of product research.
- Provide leadership to cross-functional project teams.
- Establish and maintain relationships with key opinion leaders and clinical investigators.
- Ensure compliance with regulatory requirements.
- Participate in due diligence activities and provide medical expertise in support of business development initiatives.
- Represent HI-Bio externally at scientific conferences and 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.
Who You Are
You have significant experience in clinical trials and can communicate and present relevant clinical data effectively. You are curious, creative, and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.
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.
- Experience in late-stage drug development, with a preference for nephrology and/or immuno-inflammatory indications.
- Strong knowledge of clinical trial design and execution.
- Deep understanding of regulatory requirements for drug development.
- Excellent communication skills, with the ability to effectively communicate complex medical and scientific information.
- Strong interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders.
- Ability to travel domestically and internationally, approximately 10-20% of the time.
The base compensation range for this role is $187,000 - $312,000. Base salary is determined by a combination of factors including relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs.
Why Biogen?
We are a global team with a commitment to excellence. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. We work together to deliver life-changing medicines, with every role playing a vital part in our mission.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. All qualified applicants will receive consideration for employment without regard to any protected status.
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