Medical Director, Clinical Development

Verastem•Boston, MA

2d•$250,000 - $310,000

About The Position

We are looking for a Medical Director (level dependent on qualifications) to support our growing Clinical Development team! Reporting to the Vice President of Clinical Development. The position provides medical and scientific leadership for Verastem’s potentially best-in-class KRAS G12D ON/OFF inhibitor: VS-7375 Program. This individual will initially lead the Phase 1 study of VS-7375 to develop novel combinations through dose findings/optimization, and with the opportunity to work on pivotal studies, market authorization activities, and indication expansion strategies.

Requirements

Medical Degree (M.D. or equivalent) required.
3+ years of experience in biotech / pharma industry oncology drug development (or substantial investigational therapeutics experience as a clinical investigator if not meeting industry experience requirement) is required
Knowledge of Good Clinical Practices (cGCP); comprehensive knowledge of clinical trial design; understanding of the overall global drug development process.
Knowledge of current external regulatory environment, e.g. FDA, EMA requirements
Ability to work independently and the exercise of good medical, clinical judgment in resolving critical problems not always covered by existing standards, policies and procedures.
Excellent interpersonal, verbal communication, and influencing skills.
Demonstrated ability to develop and cultivate relationships with key internal, and external, partners and stakeholders.
Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points.
Comfortable working in fast paced entrepreneurial environment, with a flexible mindset to be successful in a biotech corporate culture.
Ability to travel up to 20% of the time.

Nice To Haves

Board-certified in oncology
Experience in early phase drug development
Working knowledge on translational science

Responsibilities

Supports the design and execution of assigned clinical trial(s) and works closely with cross functional study team members to execute activities associated with the conduct of the clinical trials.
Serves as the primary medical / safety contact for assigned clinical trials, ensuring compliance and patient safety. Serve as the primary contact for medical-related inquiries from investigators, regulatory agencies, and internal/external teams, ensuring consistent protocol interpretation and clarification.
Partners with Clinical Science, Data Management, Statistical Programing to ensure data integrity. Lead regular data reviews and insight generation to guide development strategy.
Collaborates with Safety on reporting of identified adverse events (AEs), serious adverse events (SAEs), and other safety-related events. Contributes to safety profile characterization and corresponding risk mitigation strategy / plans.
Leads the interpretation and integration of preclinical, pharmacology, translational science, and clinical data to generate actionable insights for drug development. Apply deep scientific expertise to assess benefit-risk profiles, inform complex development decisions.
Authors and develop key study and regulatory documents with the cross functional team, including, but not limited to study protocol, investigator brochure, informed consent form, and clinical study reports. Contributes to scientific publications, including conference abstracts and peer-reviewed journal articles.
Represents the study / program and interacts on a regular basis with key internal / external partners and stakeholders, including key opinion leaders, clinical investigators, clinicians, scientists as well as internal leadership team and R&D. Lead and present at investigator meetings and advisory committees.
Maintains scientific and clinical knowledge in oncology and provides input on Verastem’s pipeline, translational and preclinical work.