Senior Medical Director

Verastem Oncology; Boston (MA); On-site; USD 200,000 - 300,000; Full time

Job summary

A leading company in oncology is seeking a Senior Medical Director to join their Clinical Development team in Boston. This role involves providing medical expertise, overseeing clinical trials, and ensuring compliance with protocols. The ideal candidate will have a medical degree and extensive experience in oncology clinical trials, with a strong focus on safety monitoring and regulatory interactions.

Qualifications

• At least 7 years of experience in Oncology, preferably with clinical trials experience as a Medical Monitor.
• Demonstrated experience in clinical trial safety monitoring and regulatory interactions.
• Knowledge of current Good Clinical Practices (cGCP) and clinical trial design.

Responsibilities

• Primary medical/safety contact for assigned clinical trials.
• Monitor clinical trials to ensure participant safety and protocol compliance.
• Lead investigator conference calls and support site selection.

Skills

Interpersonal skills

Verbal communication

Analytical skills

Presentation skills

Education

Medical degree

Job description

Company Profile:

At Verastem Oncology, our purpose is to create a world where no cancer patient ever runs out of options. This commitment is central to who we are as a company and the culture we nurture. We are laser focused on establishing avutometinib + defactinib as the backbone of therapy for RAS-mediated tumors. We seek individuals who share our perspective; when others see only a problem, we see an opportunity; when others give up, we step up. We partner with global leaders and their teams, and these relationships help us serve the patients who need us most. We appreciate your candidacy for the Verastem Oncology team and encourage you to learn more at www.verastem.com.

Summary:

We are looking for a Senior Medical Director to support our growing Clinical Development team! Reporting to the Head of Clinical Development, this position provides medical and scientific expertise and works closely with the Clinical Operations Team to support and execute clinical trial conduct. This individual may also serve as the lead Clinical Research Scientist on specific studies or programs within our portfolio and may serve as Clinical Lead on cross-functional program teams.

Responsibilities include:

1. Primary medical/safety contact for assigned clinical trials, ensuring protocol adherence by investigators and study teams.
2. Serve as the primary contact for all medical inquiries from investigators, regulatory agencies, and internal/external teams, ensuring consistent protocol interpretation and clarification.
3. Monitor clinical trials to ensure participant safety, data accuracy, and protocol compliance, addressing medical issues as they arise.
4. Responsible for review, assessment, escalation, documentation, and reporting of adverse events (AEs), serious adverse events (SAEs), and other safety-related events.
5. Support the clinical development of assigned programs and participate in the design and implementation of studies, providing strategic clinical sciences support.
6. Lead investigator conference calls to discuss inclusion/exclusion criteria and support site selection and patient recruitment.
7. Support the design and execution of clinical trials, working closely with clinical operations and cross-functional teams.
8. Support clinical/medical monitoring and related documentation; attend and represent the clinical sciences organization in various forums; act as the primary point of contact for clinical science activities.
9. In partnership with Clinical Operations, co-lead or lead study team meetings.
10. Interact regularly with key internal and external partners and stakeholders, including KOLs, investigators, clinicians, and scientists.
11. Collaborate to develop protocols and ICF documents, and present these to governance committees.
12. Develop data review plans and monitor clinical data for trends, ensuring CRF design supports data collection aligned with protocols.
13. Develop or provide input for clinical presentations and other materials for internal and external meetings.
14. Provide clinical input for internal documents and reports, including CSRs and regulatory submissions, and contribute to publications.
15. Maintain scientific and clinical knowledge in the relevant therapeutic areas.

Education and Experience:

• Medical degree required.
• At least 7 years of experience in Oncology, preferably with clinical trials experience as a Medical Monitor.
• Relevant therapeutic area experience preferred.
• Demonstrated experience in clinical trial safety monitoring, AE reporting, data review, and regulatory interactions.
• Knowledge of current Good Clinical Practices (cGCP), clinical trial design, and the global drug development process.
• Understanding of regulatory environments such as FDA and EMA.
• Ability to work independently and exercise good medical and clinical judgment.
• Strong interpersonal, verbal communication, and influencing skills.
• Ability to develop and nurture relationships with key partners and stakeholders.
• Excellent written communication, analytical, and presentation skills.
• Comfortable working in a fast-paced, entrepreneurial biotech environment.
• Proven ability to work independently and in teams.
• Willingness to travel up to 20%.