Clinical Development lead, Immunology, WCH

Role Summary

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.

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.

Qualifications

• Required: MD, PhD, or PharmD is required with experience in immunology, inflammation, or autoimmune disease drug development.
• Required: 3+ years’ experience in clinical development, translational science, or related roles within biotech or pharmaceutical organizations.
• Required: Experience contributing to clinical development plans, protocol design, and cross-functional development activities.
• Required: Strong communication and stakeholder management skills.
• Required: Deep understanding of regulatory requirements for drug development.
• Required: Excellent communication skills, with the ability to effectively communicate complex medical and scientific information to diverse audiences.
• Required: 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.
• Preferred: 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.

Skills

• Excellent communication skills and the ability to clearly convey complex medical and scientific information to diverse audiences.
• Strong interpersonal and collaboration abilities with the capacity to build relationships with key opinion leaders, clinical investigators, and internal stakeholders.
• Ability to influence without authority and partner effectively across disciplines.

Additional Requirements

• Hybrid-based role in South San Francisco, CA; regular commuting from US-Remote locations may be considered.