Senior Clinical Development Lead, Immunology and Indication Expansion, WCH

Biogen • San Francisco, CA

120d • $254,000 - $349,000 • Remote

About The Position

Biogen's West Coast Hub, based in South 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. Reporting in to the Head of Clinical Development, Immunology and Indication Expansion WCH, the Senior Clinical Development Lead (Senior MD), Immunology will have direct responsibility for advancing high priority clinical programs in all stages of development with a near term focus on early phase I-II programs for autoantibody driven diseases. The Senior Clinical Development Lead is an integral role requiring a blend of scientific acumen, strategic planning, and leadership. Primary responsibilities may include developing frameworks for new indications, assessing regulatory and relevant policies that could accelerate drug development timelines, designing clinical studies, and interpreting study data in close collaboration with WCH research and development teams. As a cornerstone of our clinical development team, your work will not only shape the trajectory of our WCH immunology pipeline but also contribute to the company's mission by providing vital insights into early development of research assets, external partnerships and due diligence activities. In addition, this person will also be responsible for building and managing a team of up to two direct reports, providing technical oversight and mentorship.

Requirements

• MD, PhD, or PharmD required, with subspecialty in neuroimmunology drug development strongly preferred.
• At least 6 years of experience in the biotech/pharmaceutical industry, with additional experience in clinical or academic research.
• Proven track record of leading registration-stage programs or early clinical development programs with experience filing INDs.
• Experience interacting with global regulatory authorities.
• Deep scientific and clinical understanding of neuroimmunology/autoimmune disorders.
• Demonstrated ability to work effectively with cross-functional R&D partners.
• Experience leading cross-functional teams and mentoring clinical development professionals.
• Strong interpersonal skills, with the ability to establish and maintain relationships through a highly collaborative approach.
• Strong problem-solving, conflict resolution, and analytical skills.
• Ability to facilitate discussions among cross-functional groups and drive decisions on complex issues.
• Ability to travel domestically and internationally, approximately 10-20% of the time.

Nice To Haves

• Established network of global Key Opinion Leaders (KOLs).

Responsibilities

• Lead the design and execution of neuroimmunology/autoimmune programs through First-in-Human, Proof of Biology, pivotal, global registrational filings, and life-cycle expansion, with accountability for timelines, risk mitigation, and deliverables, including protocol development, study monitoring, data review, and analysis.
• Provide leadership to cross-functional project teams, ensuring seamless collaboration across clinical operations, biometrics, and more.
• Serve as medical monitor for early phase clinical trials, prioritizing patient safety and protocol adherence.
• Establish and foster relationships with key opinion leaders and clinical investigators in the field.
• Build and lead a high-performing team of Clinical Scientists and Medical Directors, addressing various immunology indications.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree