Medical Director, Clinical Development, Oncology

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.

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.

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.
• Hightly 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.