Medical Director, Clinical Development, Oncology
Lyell Immunopharma
August 12, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Director, Clinical Development
Key Roles and Responsibilities
- Provide clinical leadership in the design, implementation, and oversight of cell therapy trials in oncology.
- Contribute meaningfully to clinical development plans (CDPs) and clinical trial protocols.
- Analyze and interpret clinical trial data; provide medical input for clinical study reports and regulatory documents.
- Ensure scientific integrity of clinical studies and compliance with GCP standards and regulatory requirements.
- Collaborate with Regulatory Affairs to support preparation and review of regulatory submissions (IND, BLA, etc.).
- Serve as a medical representative in agency meetings (e.g., FDA, EMA) as appropriate.
- Oversee monitoring and reporting of adverse events and safety signals; contribute to risk management strategies.
- Ensure ethical conduct of clinical trials and adherence to applicable regulatory guidelines.
- Work closely with Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
- Contribute medical expertise to cross-functional project teams and strategic planning.
- Support development and review of scientific content for regulatory documents and scientific communications.
- Represent the company at scientific conferences/industry meetings and interact with KOLs.
- Build and maintain scientific relationships with clinical investigators and academic centers.
Preferred Education
- MD required; MD/PhD or additional advanced training a plus.
- Board certification (current or prior) in oncology, hematology, or related field preferred.
Preferred Experience
- Minimum 5 years of clinical research experience in oncology, focused on cell therapy or immuno-oncology.
- Demonstrated experience designing, executing, and overseeing clinical trials.
- Experience with regulatory submissions and agency interactions (IND, BLA, FDA meetings) highly desirable.
- Prior industry experience in a pharmaceutical/biotech setting required.
Knowledge, Skills, and Abilities
- Deep oncology expertise; ability to analyze and communicate complex clinical data.
- Strong knowledge of regulatory requirements, GCP standards, and clinical development best practices.
- Excellent cross-functional collaboration; strong communication (written/verbal).
- Highly organized; manages multiple priorities in fast-paced, resource-constrained environments.
- Adaptability in a pre-commercial biotech setting.
- Openness to adopting new technologies, including AI-assisted tools.
Compensation/Benefits
- Salary range: $240,000–$300,000 annually; annual bonus opportunity; eligible for Equity Incentive Plan.
Key Roles and Responsibilities
- Provide clinical leadership in the design, implementation, and oversight of cell therapy trials in oncology.
- Contribute meaningfully to clinical development plans (CDPs) and clinical trial protocols.
- Analyze and interpret clinical trial data; provide medical input for clinical study reports and regulatory documents.
- Ensure scientific integrity of clinical studies and compliance with GCP standards and regulatory requirements.
- Collaborate with Regulatory Affairs to support preparation and review of regulatory submissions (IND, BLA, etc.).
- Serve as a medical representative in agency meetings (e.g., FDA, EMA) as appropriate.
- Oversee monitoring and reporting of adverse events and safety signals; contribute to risk management strategies.
- Ensure ethical conduct of clinical trials and adherence to applicable regulatory guidelines.
- Work closely with Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
- Contribute medical expertise to cross-functional project teams and strategic planning.
- Support development and review of scientific content for regulatory documents and scientific communications.
- Represent the company at scientific conferences/industry meetings and interact with KOLs.
- Build and maintain scientific relationships with clinical investigators and academic centers.
Preferred Education
- MD required; MD/PhD or additional advanced training a plus.
- Board certification (current or prior) in oncology, hematology, or related field preferred.
Preferred Experience
- Minimum 5 years of clinical research experience in oncology, focused on cell therapy or immuno-oncology.
- Demonstrated experience designing, executing, and overseeing clinical trials.
- Experience with regulatory submissions and agency interactions (IND, BLA, FDA meetings) highly desirable.
- Prior industry experience in a pharmaceutical/biotech setting required.
Knowledge, Skills, and Abilities
- Deep oncology expertise; ability to analyze and communicate complex clinical data.
- Strong knowledge of regulatory requirements, GCP standards, and clinical development best practices.
- Excellent cross-functional collaboration; strong communication (written/verbal).
- Highly organized; manages multiple priorities in fast-paced, resource-constrained environments.
- Adaptability in a pre-commercial biotech setting.
- Openness to adopting new technologies, including AI-assisted tools.
Compensation/Benefits
- Salary range: $240,000–$300,000 annually; annual bonus opportunity; eligible for Equity Incentive Plan.