Associate Director/Director, Clinical Pharmacology

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 in our efforts to establish avutometinib defactinib as the backbone of therapy for RAS-mediated tumors. We look for people 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 to 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 seeking a highly experienced candidate to join our clinical pharmacology team to lead and drive the clinical pharmacology strategies across the drug development programs. The ideal candidate will have a strong background in clinical pharmacology, pharmacokinetics, and pharmacometrics with proven experience in guiding programs from early development through regulatory submissions. In this position, you will oversee study design, data interpretation, and cross-functional collaboration to ensure the success of clinical development programs.

Responsibilities:

• Develop and execute clinical pharmacology support for all phases of drug development, ensuring alignment with corporate and regulatory goals
• Lead the design, execution, and oversight of clinical pharmacology studies, including first-in-human, dose escalation, bioavailability, bioequivalence, food-effect, DDI, and population PK studies
• Collaborate with cross-functional teams, including nonclinical, regulatory, clinical operations, and biostatistics, to integrate clinical pharmacology strategies into overall development plans
• Provide expertise in dose selection, optimization, and justification in clinical studies using modeling and simulation tools (e.g., population PK, PK/PD, exposure-response)
• Author, review, and approve clinical pharmacology sections in regulatory documents, including protocols, investigator brochures, INDs, NDAs, and other submission packages.
• Serve as a subject matter expert in interactions with regulatory agencies, preparing and presenting clinical pharmacology data to support regulatory submissions
• Support our RAF/MEK clamp avutometinib, our FAK inhibitor defactinib, our KRAS G12D inhibitor VS-7375, as well as additional anti-cancer agents as they enter development pipeline
• Stay current with emerging trends and regulatory requirements in clinical pharmacology to ensure best practices and compliance
• Oversee and manage partnerships with CROs and external consultants to ensure timely delivery of high-quality clinical pharmacology studies.
• Support business development by providing clinical pharmacology expertise for due diligence reviews and strategic evaluations.

Qualifications:

• PhD in clinical pharmacology, pharmaceutical sciences, or a related discipline with at least 6-8 years of industry experience in clinical pharmacology
• Deep understanding of pharmacokinetics, pharmacodynamics, and pharmacometrics, as well as their application in drug development
• Demonstrated track record of successful contributions to regulatory submissions (e.g., IND, NDA, BLA)
• Strong knowledge of regulatory guidelines (FDA, EMA, ICH) and experience in engaging with regulatory authorities
• Proficiency in modeling and simulation tools (e.g., NONMEM, Phoenix)
• Prior experience in oncology
• Experience with DMPK and bioanalysis is a plus
• Excellent project management, and team-building skills
• Strong written and verbal communication skills with the ability to present complex data to diverse audiences