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 immunology clinical programs, with a specific emphasis on immunological complications of transplantation. Reporting directly to the Clinical Development Lead, the MD will be a key member of the clinical development team, supporting 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 be 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.
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, with a preference for experience in transplant, nephrology, and/or immuno-inflammatory indications.
- Strong knowledge of clinical trial design and execution, including experience with adaptive trial designs and biomarker-based approaches.
- Deep understanding of regulatory requirements for drug development, including experience leading interactions with global regulatory agencies.
- Strong interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders through a highly collaborative approach.
- Ability to travel domestically and internationally, approximately 10-20% of the time.
Additional Information
The base compensation range for this role is $187,000 - $312,000. Base salary is determined by a combination of factors including, but not limited to, job-related years of 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. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
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