Clinical Development lead, Immunology, WCH
About The Position
About This Role: The Clinical Development Lead, Immunology, based within Biogen’s West Coast Hub (WCH), will provide strategic leadership to advance our Immunology programs, ensuring innovative clinical development approaches and well-informed trial designs. Operating at the intersection of program strategy, disease-area insight, and clinical execution, you will partner closely with Medical and Clinical Development leadership to translate strategy into high-quality development plans. Your role is pivotal in managing external collaborations and gaining comprehensive knowledge of current literature related to the indications and products in development. Supporting regulatory interactions and collaborating with Medical Affairs and Commercial colleagues are integral parts of your responsibilities. The scope of this role may emphasize program strategy and execution or disease-area strategy, tailored to your strengths, experience, and portfolio needs. What You’ll Do: Contribute to the development and execution of clinical development strategies for immunology programs across early through late-stage development. Inform clinical trial design decisions, including patient populations, endpoints, duration, and feasibility considerations. Support the development and maintenance of Clinical Development Plans (CDPs) in partnership with Clinical and Medical Development leadership. Translate scientific, clinical, and external precedents into clear strategic recommendations to guide program decisions. Partner cross-functionally to ensure alignment between strategy and execution. Lead or co-lead protocol development, amendments, and supporting documents, as appropriate. Prepare materials and contribute to discussions for development governance forums and senior leadership reviews. Support disease-area strategy development and external engagement through scientific and clinical narratives. This position is a hybrid-based role in South San Francisco, CA. Consideration may be given to individuals able to commute to CA regularly from US-Remote locations. Who You Are: You are a curious, strategic, and collaborative clinical development leader who thrives in ambiguity and continuously seeks to learn and improve. Passionate about improving the lives of patients with immune-mediated or autoimmune diseases, you excel in translating complex scientific and clinical information into actionable development strategies. You have the ability to influence without authority and partner effectively across disciplines. Experienced in framing trade-offs and decision points for senior leadership, you are adaptable, able to flex between program-level strategy and disease area depth as needed.
Requirements
- MD, PhD, or PharmD is required with experience in immunology, inflammation, or autoimmune disease drug development.
- 3+ years’ experience in clinical development, translational science, or related roles within biotech or pharmaceutical organizations.
- Experience contributing to clinical development plans, protocol design, and cross-functional development activities.
- Strong communication and stakeholder management skills.
- Deep understanding of regulatory requirements for drug development.
- Excellent communication skills, with the ability to effectively communicate complex medical and scientific information to diverse audiences.
- 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.
Nice To Haves
- Relevant disease area experience (e.g., Graves’ disease/endocrinology, neuroimmunology, or other immune-mediated conditions) and/or experience in asset- or program-level strategic leadership is a plus.
Responsibilities
- Contribute to the development and execution of clinical development strategies for immunology programs across early through late-stage development.
- Inform clinical trial design decisions, including patient populations, endpoints, duration, and feasibility considerations.
- Support the development and maintenance of Clinical Development Plans (CDPs) in partnership with Clinical and Medical Development leadership.
- Translate scientific, clinical, and external precedents into clear strategic recommendations to guide program decisions.
- Partner cross-functionally to ensure alignment between strategy and execution.
- Lead or co-lead protocol development, amendments, and supporting documents, as appropriate.
- Prepare materials and contribute to discussions for development governance forums and senior leadership reviews.
- Support disease-area strategy development and external engagement through scientific and clinical narratives.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
