Director, Clinical Scientist

Verastem•Needham, MA

12d•$200,000 - $260,000

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.