The Director, Clinical Scientist provides clinical and scientific leadership for assigned oncology studies and programs. This individual serves as a key member of Study and Program Teams, 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 the clinical/scientific design and execution of assigned clinical trial(s), partnering closely with cross-functional study and program teams.
- Ensures clinical data integrity through hands-on, ongoing review, analysis, and interpretation of safety, efficacy, pharmacokinetic, biomarker, and other study data; identifies emerging trends and translates study-level findings into program-level insights and recommendations.
- Oversees clinical science support from partner CROs and creates and refines data review and cleaning processes, tools, and workflows to improve efficiency, consistency, and data quality.
- Authors and leads key study and clinical/regulatory documents, including protocols and synopses, informed consent forms, investigator brochures, briefing books, safety updates, clinical study reports, and clinical sections of regulatory submissions and responses.
- Contributes to integrated clinical development plans and study/program strategy, including key development options, risks, and decision points.
- Partners with investigators and internal/external stakeholders to support protocol interpretation, appropriate scientific/medical oversight, and compliance with GCP/GxP and applicable regulatory requirements.
- Leads or supports investigator meetings, protocol training, advisory boards, steering committees, and other scientific forums; develops and delivers clear presentations for internal and external audiences.
- Supports scientific communication through literature review and development/review of abstracts, presentations, and manuscripts; maintains current knowledge of oncology, clinical development, and the external regulatory/scientific environment, and develops strong collaborative relationships across Verastem and with external scientific partners.
Required qualifications
- Master's degree (MS) in life sciences or a related discipline with 12+ years of relevant work experience required.
- Progressive biotech/pharma clinical development experience, with demonstrated leadership in oncology clinical strategy, study execution, and clinical data and safety analysis.
- Strong knowledge of Good Clinical Practices (GCP/GxP), clinical trial design, the global drug development process, and current regulatory expectations (e.g., FDA and EMA).
- Demonstrated ability to lead and influence cross-functional matrix teams, work independently, and exercise sound clinical/scientific judgment in a fast-paced entrepreneurial environment.
- Excellent analytical, interpersonal, verbal communication, influencing, and presentation skills, including the ability to distill complex information into key considerations and decision points.
- Ability to travel up to 20% of the time.
Preferred qualifications
- Advanced degree in life sciences or clinical practice experience highly preferred (e.g., R.N., PhD, PharmD).
- Prior experience with global clinical trials and NDA/BLA or other major regulatory submissions preferred.
- Experience in oncology drug development across multiple stages of clinical development preferred.
The base salary range ($200,000 - $260,000) provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
