Director, Clinical Pharmacology

Company Profile:

At Verastem Oncology, we address urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve launched this novel/novel combination therapy in the U.S. and are exploring pathways for Europe and Japan. We continue to advance our pipeline of drugs to help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. This is an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. 

Position Summary

Lead clinical pharmacology and model informed drug development (MIDD) for small molecule oncology programs from first-in-human studies through registration. Integrate nonclinical, translational, and clinical evidence to guide study design, dose and regimen optimization, and regulatory decisions. This role owns clinical pharmacology strategy and study support, partnering closely with pharmacometricians on modeling and simulation. The position is expected to align primarily with Director or Senior Director scope; experienced Associate Director candidates will be considered.

Key Responsibilities

• Set integrated clinical pharmacology and MIDD strategy for one or more programs, including first in human dosing, escalation, dose optimization, combinations, and registration planning.


• Design and oversee clinical pharmacology studies and assessments, including PK/PD and biomarker sampling, food effect, bioavailability and bioequivalence, formulation bridging, drug interactions, organ impairment, and other special populations.


• Lead clinical pharmacology input to protocols, study execution, data review, analyses, interpretation, and reports; resolve emerging dosing, PK, sampling, and bioanalytical issues with study teams.


• Integrate PK, PD, efficacy, safety, biomarkers, and translational findings to recommend doses and regimens; use ADME/DMPK evidence to address human PK, metabolism, transporters, metabolites, and interaction risk.


• Define quantitative questions and partner with pharmacometricians on population PK, PK/PD, exposure response, and simulation; assess model assumptions, uncertainty, and clinical relevance.


• Provide scientific oversight of PK bioanalysis, including analyte selection, assay requirements, data quality, and interpretation; guide external clinical pharmacology and quantitative partners.


• Author and review clinical pharmacology content for protocols, Investigator’s Brochures, study reports, regulatory submissions, labeling, and health authority responses.

Qualifications

• PhD, PharmD, MD, or equivalent advanced degree in clinical pharmacology, pharmacology, pharmaceutical sciences, or a related field; approximately 6+ years of relevant industry experience.


• Demonstrated leadership in clinical pharmacology strategy, clinical study design and execution, PK/PD, and dose optimization; small molecule oncology experience strongly preferred.


• Strong working knowledge of MIDD, pharmacometrics, ADME/DMPK, translational PK/PD, biomarkers, and bioanalysis; hands-on modeling experience is useful but not required.


• Sound scientific judgment and ability to turn emerging data into decisions across clinical teams; regulatory submission and health authority experience preferred, especially at senior levels.