Medical Director, Clinical Development, Oncology

Director, Clinical Development — Key Roles and Responsibilities

Clinical Trial Leadership & Execution
- 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.

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 applicable regulatory guidelines.

Cross-Functional Collaboration
- Work 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.

External Engagement
- Represent the company at scientific conferences/industry meetings/KOL interactions.
- Build and maintain scientific relationships with clinical investigators and academic centers.

Preferred Education & Experience
- MD required; MD/PhD or additional advanced training a plus.
- Board certification (current or prior) in oncology, hematology, or related field preferred.
- 5+ years of clinical research experience in oncology (cell therapy/immuno-oncology focus).
- Demonstrated experience designing, executing, and overseeing clinical trials.
- 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/communicate complex clinical data.
- Strong knowledge of regulatory requirements, GCP, and clinical development best practices.
- Excellent cross-functional collaboration without direct authority.
- Strong written/verbal communication.
- Highly organized; manage multiple priorities in a fast-paced environment.
- 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; opportunity for annual bonus; eligible for Equity Incentive Plan.