Senior Medical Director, Clinical Development

Verastem Oncology

. Provide medical and scientific leadership for late-phase solid tumor clinical development, focused on the VS-7375 KRAS G12D ON/OFF inhibitor program .

Posted 10/27/2026full-timeBoston • Massachusetts • United StatesSenior💰 $320,000 - $350,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in late-phase solid tumor clinical development, including trial design, medical monitoring, and regulatory submission processes. Possesses strong knowledge of Good Clinical Practice and the global drug development process, with a proven ability to interpret complex data and communicate effectively with stakeholders.

Highest-signal resume keywords

Medical Degree (MD)Oncology Clinical DevelopmentPhase 3 Pivotal TrialsGood Clinical Practice (GCP)NDA Submission Preparation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Trial DesignMedical MonitoringData InterpretationClinical Study ReportingBenefit-Risk AssessmentAdverse Event GradingRegulatory FilingClinical Query ResolutionSafety Signal ReviewResource Planning

Soft Skills

Interpersonal SkillsWritten CommunicationPresentation SkillsInfluencing SkillsCollaboration

Industry Keywords

BiotechnologyPharmaceutical IndustryOncologyFDA RequirementsEMA RequirementsRECISTSurvival EndpointsClinical OperationsClinical ScienceHealth Authority Interactions

About the role

Key responsibilities & impact

Provide medical and scientific leadership for late-phase solid tumor clinical development, focused on the VS-7375 KRAS G12D ON/OFF inhibitor program
Lead the medical aspects of assigned Phase 3 pivotal trials and oversee medical monitoring
Lead trial design and medical execution with Clinical Science, Clinical Operations, Biostatistics, Regulatory Affairs, and other study team members
Establish study plans, timelines, resource needs, and budget inputs; monitor milestones, identify risks, and resolve clinical issues
Serve as primary medical monitor and contact for assigned trials; respond to investigator inquiries and assess eligibility questions
Oversee internal and external medical monitoring, including CRO support; review safety, efficacy, laboratory, and protocol deviation data
Collaborate on adverse-event and safety-signal review, benefit-risk assessment, risk mitigation, and data monitoring committee activities
Support clinical data reviews, medical query resolution, interim analyses, database lock, and final reporting
Interpret efficacy, safety, pharmacology, and translational data to inform development and regulatory filing decisions
Author and review protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory submission sections
Contribute to NDA and applicable MAA preparation and filing, including clinical summaries, benefit-risk assessments, integrated analyses, and responses to health authorities
Prepare briefing documents and clinical presentations, participate in agency interactions, and support inspection readiness
Build relationships with investigators, key opinion leaders, advisors, and stakeholders; lead presentations and contribute to scientific publications

Requirements

What you’ll need

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 in design, conduct, medical monitoring, and interpretation of Phase 3 pivotal studies, including trial 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, with 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
Ability to work independently and collaboratively in a matrixed environment, manage competing priorities, and achieve clinical development milestones
Excellent interpersonal, written communication, presentation, and influencing skills
Ability to travel up to 25% of the time