Senior Clinical Development Lead Neuroimmunology, Immunology & Indication Expansion, WCH

Biogen•San Francisco, CA

7d•$254,000 - $349,000•Remote

About The Position

About This Role The Senior Clinical Development Lead, Neuroimmunology, based within Biogen’s West Coast Hub (WCH), will lead the development of one or more programs in a growing portfolio of early-phase immunology assets and indication expansion opportunities. Reporting to the Head of Clinical Development, Immunology and Indication Expansion (WCH), this role will drive high-priority clinical programs across all stages of development, with an initial focus on early-phase studies in autoantibody-driven diseases such as myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy (CIDP). 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 may also be responsible for building and managing a team, providing technical oversight and mentorship. What You’ll Do 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. This includes accountability for timelines, risk mitigation, and key 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, and 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 the immunology field and disease areas related to active or prospective clinical development programs. Build and lead a high-performing clinical development team, including all phases of development addressing different immunology indications Who You Are You are a strategic thinker with a passion for advancing clinical development in neuroimmunology and immunology. Your expertise in neuroimmunology and autoimmune disorders is complemented by your ability to lead and inspire cross-functional teams. You thrive in collaborative environments and are adept at building relationships with external stakeholders, including key opinion leaders and clinical investigators. Your problem-solving skills are exceptional, and you have a track record of driving complex decisions with clarity and precision.

Requirements

MD and/or PhD/PharmD is required with specialization in neurology/ neuroimmunology and prior drug development experience in these therapeutic areas, is strongly preferred.
At least 3 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 one or more immunology or neuroimmunology/autoimmune programs from First-in-Human through Proof of Biology, pivotal trials, global registration, and life-cycle expansion. This includes accountability for timelines, risk mitigation, and key 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, and 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 the immunology field and disease areas related to active or prospective clinical development programs.
Build and lead a high-performing clinical development team, including all phases of development addressing different 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