Summary
The Director, Clinical Scientist provides clinical and scientific leadership for assigned oncology studies and programs, leading clinical/scientific execution, data review and interpretation, and development of study and regulatory documents to support development strategy and potential market authorization applications.
Responsibilities
- Leads clinical/scientific design and execution of assigned clinical trial(s) with cross-functional study and program teams.
- Ensures clinical data integrity via ongoing review, analysis, and interpretation of safety, efficacy, pharmacokinetic, biomarker, and other study data; translates trends into program-level insights.
- Oversees clinical science support from partner CROs; creates and refines data review/cleaning processes, tools, and workflows.
- Authors and leads key study and clinical/regulatory documents (protocols/synopses, informed consent forms, investigator brochures, briefing books, safety updates, clinical study reports, and regulatory submission responses).
- Contributes to integrated clinical development plans and study/program strategy.
- Partners with investigators and stakeholders for protocol interpretation, medical oversight, and compliance with GCP/GxP and applicable regulations.
- Leads/supports investigator meetings, protocol training, advisory boards, steering committees; delivers presentations.
- Supports scientific communication (literature review; abstracts, presentations, manuscripts) and maintains oncology/regulatory knowledge.
Required qualifications
- MS in life sciences or related field with 12+ years relevant experience.
- Biotech/pharma clinical development experience with oncology clinical strategy, study execution, and clinical data/safety analysis leadership.
- Strong GCP/GxP knowledge, clinical trial design, global drug development, and regulatory expectations (FDA/EMA).
- Ability to lead and influence cross-functional matrix teams; independent work and sound judgment.
- Excellent analytical and communication/presentation skills.
- Travel up to 20%.
Preferred qualifications
- Advanced degree or clinical practice experience (e.g., R.N., PhD, PharmD).
- Global clinical trials and NDA/BLA (or major regulatory submission) experience.
- Oncology drug development across multiple clinical stages.
Benefits
- Base salary range: $200,000β$260,000; eligible for annual bonus, equity compensation, and a competitive benefits package.