Senior Medical Director

Verastem•Boston, MA

3d•$320,000 - $350,000

About The Position

Verastem Oncology is seeking a Medical Director/Senior Medical Director, with level dependent on qualifications, to provide medical and scientific leadership for late-phase solid tumor clinical development, focusing on the VS-7375 KRAS G12D ON/OFF inhibitor program. The role leads the medical aspects of assigned Phase 3 pivotal trials, oversees medical monitoring, and contributes to regulatory filing and marketing authorization activities. The position requires experience conducting late-phase oncology trials and preparing clinical content for regulatory submissions within a cross-functional, matrixed team. The Senior Medical Director will collaborate across clinical, operational, regulatory, statistical, and other functions to design and execute trials, monitor study progress and safety, interpret clinical data, and support development decisions. The role also authors and reviews clinical and regulatory documents, contributes directly to NDA and applicable MAA preparation and filing, supports health authority interactions, and engages with investigators, key opinion leaders, and internal stakeholders. Travel may be required up to 25% of the time.

Requirements

Medical degree (MD or equivalent).
At least 5 years of biotechnology or pharmaceutical industry experience in oncology clinical development, including direct responsibility for late-phase solid tumor trials.
Demonstrated experience designing, conducting, medically monitoring, and interpreting Phase 3 pivotal studies, including delivery through key analyses and clinical study reporting.
Hands-on experience contributing clinical content to at least one oncology marketing application (NDA or equivalent), including submission preparation and filing, and direct involvement in health authority interactions and responses to agency questions.
Strong knowledge of Good Clinical Practice, the global drug development process, FDA and EMA requirements, and oncology efficacy and safety assessments, including RECIST, survival endpoints, and adverse event grading.
Sound medical judgment and ability to interpret complex data, assess benefit-risk, resolve clinical issues, and communicate clear recommendations to investigators and cross-functional teams.
Ability to work independently and collaboratively in a matrixed environment, manage competing priorities, and achieve clinical development milestones in a fast-paced biotechnology setting.
Excellent interpersonal, written communication, presentation, and influencing skills, with ability to build effective internal and external relationships.
Ability to travel up to 25% of the time.

Responsibilities

Lead the design and medical execution of assigned late-phase solid tumor trials in collaboration with Clinical Science, Clinical Operations, Biostatistics, Regulatory Affairs, and other study team members.
Partner with Clinical Operations to establish study plans, timelines, resource needs, and budget inputs; monitor milestones, identify risks, and resolve clinical issues affecting enrollment, trial conduct, data quality, and study completion.
Serve as primary medical monitor and medical contact for assigned trials; respond to investigator inquiries, assess eligibility questions, interpret protocols, and guide participant clinical management in accordance with the protocol.
Oversee internal and external medical monitoring, including CRO support; review emerging safety and efficacy data, clinically significant laboratory findings, and protocol deviations, escalating issues as needed.
Collaborate with Pharmacovigilance on medical review of adverse events, serious adverse events, and emerging safety signals; characterize safety, assess benefit-risk, develop risk mitigation measures, and support independent data monitoring committee reviews and follow-up actions.
Partner with Clinical Science, Data Management, Biostatistics, and Statistical Programming on clinical data reviews, medical query resolution, and preparation of clean, complete datasets for interim analyses, database lock, and final reporting.
Interpret and integrate efficacy, safety, pharmacology, and translational data to inform development decisions, indication expansion, and clinical evidence for regulatory filings.
Author and review protocols, amendments, investigator brochures, informed consent forms, clinical study reports, and clinical sections of regulatory submissions; ensure consistency of the clinical narrative and supporting evidence.
Contribute directly to NDA and, as applicable, MAA preparation and filing; develop and review clinical summaries and benefit-risk assessments, support integrated efficacy and safety analyses, and respond to health authority questions.
Partner with Regulatory Affairs to prepare briefing documents and clinical presentations for health authority meetings; participate in agency interactions and support submission review and inspection readiness.
Build relationships with investigators, key opinion leaders, external medical advisors, and internal stakeholders; lead clinical presentations at investigator meetings and advisory boards, communicate program updates to leadership, and contribute to abstracts, manuscripts, and scientific presentations.