Medical Director, Clinical Development - Oncology
Lyell ImmunopharmaSouth San Francisco, California, United States · Posted 2 months agoDescription
The Director, Clinical Development will serve as a key clinical contributor embedded in Lyell's small, high-impact development team. This individual contributor role is responsible for providing medical and scientific leadership across one or more clinical trials, supporting protocol development, regulatory interactions, and data interpretation as Lyell advances toward its first approval and commercial launch.
KEY ROLES AND RESPONSIBILITIES
Clinical Trial Leadership & Execution
- 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.
Regulatory & Compliance
- 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 all applicable regulatory guidelines.
Cross-Functional Collaboration
- Work closely with Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
- Contribute medical expertise to support cross-functional project teams and strategic planning.
- Support development and review of scientific content for regulatory documents and scientific communications.
External Engagement
- Represent Lyell at scientific conferences, industry meetings, and in interactions 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 a related field preferred.
PREFERRED EXPERIENCE
- Minimum 5 years of clinical research experience in oncology, with a focus on cell therapy or immuno-oncology.
- Demonstrated experience in the design, execution, and oversight of clinical trials.
- Experience with regulatory submissions and agency interactions (IND, BLA, FDA meetings) highly desirable.
- Prior industry experience in a pharmaceutical or biotech setting required.
KNOWLEDGE, SKILLS AND ABILITIES
- Deep scientific expertise in oncology; ability to analyze and communicate complex clinical data to diverse audiences.
- Strong knowledge of regulatory requirements, GCP standards, and clinical development best practices.
- Excellent cross-functional collaboration skills; ability to work effectively across disciplines without direct authority.
- Strong written and verbal communication skills; comfortable engaging with external experts and internal senior leaders.
- Highly organized and able to manage multiple priorities in a fast-paced, resource-constrained environment.
- Demonstrated adaptability: thrives in a pre-commercial biotech setting with evolving priorities and a leaner organizational infrastructure.
- Openness to adopting new technologies, including AI-assisted tools for clinical data synthesis and regulatory workflows; demonstrated willingness to learn and adapt as new capabilities are introduced into the development environment.
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