Senior Clinical Development Lead, Immunology and Indication Expansion, WCH

Role Summary

Senior Clinical Development Lead, Immunology, based within Biogen’s West Coast Hub (WCH) in South San Francisco, leads the development of one or more early-phase immunology programs and indication-expansion opportunities. Reports to the Head of Clinical Development, Immunology and Indication Expansion (WCH) and drives high-priority clinical programs across development stages, with an initial focus on early-phase (I–II) studies in autoantibody-driven diseases such as Graves’ disease, myasthenia gravis, and CIDP.

Responsibilities

• Lead the design and execution of one or more immunology or neuroimmunology/autoimmune programs from First-in-Human through Proof of Biology, pivotal trials, global registration, and life-cycle expansion, including timelines, risk mitigation, and deliverables such as protocol development, study monitoring, data review, and analysis.
• Provide leadership to cross-functional project teams with peers from clinical operations, biometrics, clinical pharmacology, biomarker sciences, regulatory affairs, and medical writing, among others.
• Serve or oversee as medical monitor for early-phase clinical trials, ensuring patient safety, protocol adherence, and timely issue resolution.
• Establish and maintain relationships with key opinion leaders and clinical investigators in immunology and related disease areas.
• Build and lead a high-performing clinical development team across all phases addressing different immunology indications.

Qualifications

• Required: MD, PhD, or PharmD; subspecialty expertise in endocrinology or neuroimmunology or prior drug development experience in these areas strongly preferred.
• Required: At least 6 years in biotech/pharmaceutical industry with additional clinical or academic research experience.
• Required: Proven track record of leading registration-stage programs or early development programs with IND filing experience.
• Required: Experience interacting with global regulatory authorities.
• Required: Deep scientific and clinical understanding of neuroimmunology/autoimmune disorders; ability to work effectively with cross-functional R&D partners; experience leading cross-functional teams and mentoring professionals.
• Required: Strong interpersonal, problem-solving, conflict resolution, and analytical skills; ability to drive decisions in cross-functional groups.
• Required: Ability to travel domestically and internationally, approximately 10-20% of the time.
• Preferred: Established network of global Key Opinion Leaders (KOLs).

Skills

• Strategic thinking and leadership in clinical development for immunology.
• Strong collaboration and relationship-building with external stakeholders and internal partners.
• Exceptional problem-solving and decision-making capabilities in complex development programs.

Additional Requirements

• Remote-US talent considered, with ideal placement near the West Coast site in California. Travel is expected.