Medical Director, Clinical Development, Oncology
Lyell Immunopharma
6 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
The Director, Clinical Development will provide medical and scientific leadership across one or more oncology cell therapy clinical trials, supporting protocol development, regulatory interactions, and data interpretation as the program advances toward approval and launch.
Key Roles and Responsibilities
- Provide clinical leadership in the design, implementation, and oversight of cell therapy trials in oncology.
- Contribute 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 and compliance with GCP standards and regulatory requirements.
- Collaborate with Regulatory Affairs on regulatory submissions (e.g., IND, BLA).
- Serve as a medical representative in agency meetings (e.g., FDA, EMA) as appropriate.
- Oversee monitoring/reporting of adverse events and safety signals; contribute to risk management.
- Work with Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
- Contribute medical expertise to cross-functional teams and strategic planning.
- Represent the company at scientific conferences, industry meetings, and with KOLs.
Preferred Education
- MD required; MD/PhD or additional advanced training a plus.
- Board certification in oncology/hematology (current or prior) preferred.
Preferred Experience
- 5+ years clinical research experience in oncology (cell therapy or immuno-oncology preferred).
- 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 pharma/biotech required.
Knowledge/Skills/Abilities
- Deep oncology expertise; ability to analyze and communicate complex clinical data.
- Knowledge of regulatory requirements and GCP; strong cross-functional collaboration and communication.
- Organized, able to manage multiple priorities in a fast-paced environment; adaptable and open to 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 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 and compliance with GCP standards and regulatory requirements.
- Collaborate with Regulatory Affairs on regulatory submissions (e.g., IND, BLA).
- Serve as a medical representative in agency meetings (e.g., FDA, EMA) as appropriate.
- Oversee monitoring/reporting of adverse events and safety signals; contribute to risk management.
- Work with Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
- Contribute medical expertise to cross-functional teams and strategic planning.
- Represent the company at scientific conferences, industry meetings, and with KOLs.
Preferred Education
- MD required; MD/PhD or additional advanced training a plus.
- Board certification in oncology/hematology (current or prior) preferred.
Preferred Experience
- 5+ years clinical research experience in oncology (cell therapy or immuno-oncology preferred).
- 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 pharma/biotech required.
Knowledge/Skills/Abilities
- Deep oncology expertise; ability to analyze and communicate complex clinical data.
- Knowledge of regulatory requirements and GCP; strong cross-functional collaboration and communication.
- Organized, able to manage multiple priorities in a fast-paced environment; adaptable and open to AI-assisted tools.
Compensation/Benefits
- Salary range: $240,000–$300,000 annually; annual bonus opportunity; eligible for Equity Incentive Plan.