About the Company
A growing oncology biotechnology company is seeking an experienced Clinical Development Director to support its clinical development programs. The engagement begins as a contract position with the potential to transition into a permanent role as the company advances through its next stage of funding.
The Role
The Clinical Development Director will oversee the design, execution, and management of early-stage oncology clinical trials. This role is responsible for ensuring clinical studies are conducted efficiently while supporting regulatory submissions, safety monitoring, and cross-functional collaboration throughout the clinical development process.
The successful candidate will provide strategic medical oversight, analyze clinical data, contribute to regulatory documentation, and communicate study results to internal stakeholders and regulatory authorities.
Key Responsibilities
Clinical Development & Strategy
- Oversee the design and conduct of clinical trials.
- Assess operational feasibility and support study execution.
- Monitor study progress and oversee study close-out activities.
- Develop communication plans and status reporting throughout the clinical program.
Medical & Scientific Leadership
- Conduct medical reviews and evaluate safety and efficacy data.
- Assess protocol conduct and identify participant safety concerns.
- Provide analysis and interpretation of clinical trial data.
- Present findings and recommendations to internal stakeholders.
Regulatory & Documentation
- Author clinical protocols.
- Contribute to Clinical Study Reports (CSRs), Investigator's Brochures (IBs), IND summary documents, Clinical Trial Applications (CTAs), Informed Consent Forms (ICFs), training materials, and other regulatory documentation.
- Support regulatory submissions and scientific publications.
Qualifications
- MD, MD/PhD, or equivalent advanced degree.
- Experience within the pharmaceutical, biotechnology, or related life sciences industry.
- Experience leading global early-stage oncology clinical trials.
- Strong understanding of clinical development, medical monitoring, and regulatory documentation.
- Ability to analyze, interpret, and communicate complex clinical data.
Compensation
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