Associate Medical Director, Clinical Development, Immunology
Biogen
Summary
Clinical Development, Immunology – West Coast Hub at Biogen seeks a talented Associate Medical Director to join our team. The candidate will contribute to clinical trial design and execution, focusing on early-phase development for proof of biology (PoB) and proof of clinical concept (PoC) decision-making in autoantibody-driven diseases such as IgA nephropathy.
Job description
About the Role
Clinical Development, Immunology – West Coast Hub at Biogen seeks a talented Associate Medical Director to join our team. The candidate will contribute to clinical trial design and execution, focusing on early-phase development for proof of biology (PoB) and proof of clinical concept (PoC) decision-making in autoantibody-driven diseases such as IgA nephropathy.
The role requires a strong blend of scientific acumen, tactical trial execution, and collaborative leadership. Primary responsibilities will include contributing to clinical development frameworks, designing robust protocols, and interpreting study data in close partnership with internal research and development teams.
Responsibilities
- Partner with cross-functional teams including Clinical Pharmacology, Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to advance early-phase drug development programs
- Contribute to clinical trial protocol design, development and execution for early phase studies
- Provide medical monitoring, clinical execution, and oversight of clinical studies to ensure patient safety
- Serve as a key contact for the CRO and investigators to provide responses to protocol related questions
- Provide scientific expertise to internal and external stakeholders
- Support data interpretation and clinical reporting for early phase clinical studies
- Support preparation for health authority interaction and contribute to responses for regulatory questions related to clinical development activities
- Support risk mitigation strategies and clinical input for safety management plans
- Provide content for clinical study documents such as protocols, amendments, investigator brochures, clinical study reports, and briefing materials
- Champion patient-centered drug development approaches by incorporating disease burden, feasibility and patient experience considerations into study design
Qualifications
The candidate is passionate about advancing clinical development in immunology and improving the lives of patients with immune-mediated diseases. Expertise in nephrology and autoimmune disorders helps provide input for complex scientific and clinical information into actionable development strategies. The individual will have the ability to partner effectively across disciplines.
Required Skills
- Board-certified or board-eligible MD/DO (or equivalent), MD/PhD, or PharmD with relevant experience required
- Subspecialty experience in nephrology or autoimmune disorders or prior drug development experience in nephrology or autoimmune diseases strongly preferred
- 1-2+ years' experience in the biotech/pharmaceutical industry with additional experience in clinical research
- Prior experience in medical monitoring or investigator/sub-investigator role
- Experience contributing to clinical study execution and/or oversight and working cross-functionally with R&D partners
- Strong communication skills (written and verbal)
- Ability to manage multiple priorities in fast paced environment
- Ability to travel domestically and internationally, as required for business needs
Preferred Skills
- Relevant disease area experience (e.g., immune-mediated conditions)
- Understanding of regulatory requirements for drug development
- Established network of Key Medical Experts (KMEs) and Key Opinion Leaders (KOLs)
Requirements
- Board-certified or board-eligible MD/DO (or equivalent), MD/PhD, or PharmD with relevant experience required
- Subspecialty experience in nephrology or autoimmune disorders or prior drug development experience in nephrology or autoimmune diseases strongly preferred
- 1-2+ years' experience in the biotech/pharmaceutical industry with additional experience in clinical research
- Prior experience in medical monitoring or investigator/sub-investigator role
- Experience contributing to clinical study execution and/or oversight and working cross-functionally with R&D partners
- Strong communication skills (written and verbal)
- Ability to manage multiple priorities in fast paced environment
- Ability to travel domestically and internationally, as required for business needs
- Relevant disease area experience (e.g., immune-mediated conditions)
- Understanding of regulatory requirements for drug development
- Established network of Key Medical Experts (KMEs) and Key Opinion Leaders (KOLs)
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- 15 Days Paid Vacation
- End-of-Year Shutdown
- 12 Paid Holidays
- 80 Hours Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.