Vice President, Clinical Development

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response.  We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. 

The Vice President, Clinical Development is a senior leadership role within Lyell’s development organization and a standing member of the cross-functional leadership team. This individual is accountable for the strategy, execution, and scientific integrity of assigned clinical development programs at Lyell. The VP will bring independent clinical and strategic direction to shape Lyell’s clinical development approach and drive regulatory excellence across assigned programs.

This role can be based out of either our Seattle, WA or South San Francisco, CA office.

KEY ROLES AND RESPONSIBILITIES

Strategic Clinical Leadership

• Lead the design, implementation, and oversight of clinical trials for cell therapy products in oncology.
• Substantially develop and own the Clinical Development Plan (CDP) and clinical trial protocols for assigned programs.
• Analyze and interpret clinical trial data; provide authoritative medical input for clinical study reports.
• Ensure scientific integrity across clinical studies and full compliance with GCP standards and regulatory requirements.
• Serve as a standing member of Lyell’s cross-functional leadership team; contribute to enterprise-level strategic decision-making.

Regulatory Leadership

• Collaborate with and provide senior medical expertise to Regulatory Affairs in the preparation and review of regulatory submissions (IND, BLA, etc.).
• Represent Lyell as a senior medical spokesperson in meetings with regulatory agencies (e.g., FDA, EMA).
• Oversee monitoring and reporting of adverse events and safety signals; lead development and implementation of risk management strategies.
• Ensure ethical conduct of clinical trials and adherence to all applicable regulatory guidelines.

Cross-Functional & Team Leadership

• Provide guidance and mentorship to clinical development team members; actively support professional development across the function.
• Lead cross-functional project teams spanning Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
• Provide senior medical expertise to support product development strategy and launch readiness planning.
• Develop and review scientific content for regulatory documents and scientific communications.

External Engagement

• Represent Lyell at key scientific congresses and professional meetings; engage with KOLs, investigators, and academic centers.
• Build and sustain strong scientific relationships with external collaborators to support evidence generation and program advancement.
• Gather and synthesize external insights to inform clinical strategy and Medical Affairs collaboration.

PREFERRED EDUCATION

• MD or MD/PhD required.
• Board certification (current or prior) in oncology, hematology, or a related field strongly preferred.

PREFERRED EXPERIENCE

• Minimum 12+ years of pharmaceutical/biotech industry experience; 8+ years of clinical research experience in oncology.
• Prior experience in cell therapy, immuno-oncology, gastrointestinal oncology, or hematologic malignancies strongly preferred.
• Demonstrated experience in the design, execution, and oversight of pivotal clinical trials.
• Proven track record of independently leading clinical strategy for a specific asset or program, with experience spanning both early-phase (Phase 1/2) and pivotal-stage development.
• Substantive experience with regulatory submissions and agency interactions (IND, BLA, FDA/EMA meetings) required.
• Launch experience highly desirable.

KNOWLEDGE, SKILLS AND ABILITIES

• Deep scientific and clinical expertise in oncology; ability to analyze, interpret, and communicate complex data to executive and external audiences.
• In-depth knowledge of regulatory requirements, GCP standards, and clinical development best practices.
• Proven leadership capability — both with and without formal authority; able to drive alignment across senior cross-functional stakeholders.
• Exceptional written, verbal, and presentation skills; comfortable representing Lyell externally with regulators, investigators, and KOLs.
• Strong strategic acumen and ability to drive multiple concurrent initiatives in a resource-constrained environment.
• Demonstrated adaptability: comfortable operating in a fast-moving, pre-commercial biotech environment with evolving priorities and a leaner organizational infrastructure; able to lead a team effectively through ambiguity and change.
• Curiosity about and openness to emerging technologies, including AI-powered tools for clinical intelligence and evidence generation; willingness to evaluate and champion new capabilities that improve how the development team operates.