Director, Clinical Pharmacology

Verastem • Boston, MA

2d • $230,000 - $270,000

About The Position

Verastem Oncology is seeking a clinical pharmacology leader to guide clinical pharmacology and model-informed drug development (MIDD) for small-molecule oncology programs, from first-in-human studies through registration. The role integrates nonclinical, translational, and clinical evidence to guide study design, dose and regimen optimization, and regulatory decisions. It owns clinical pharmacology strategy and study support and partners 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 also be considered.

Requirements

• 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.
• Strong working knowledge of MIDD, pharmacometrics, ADME/DMPK, translational PK/PD, biomarkers, and bioanalysis.
• Sound scientific judgment and the ability to turn emerging data into decisions across clinical teams.

Nice To Haves

• Small-molecule oncology experience is strongly preferred.
• Hands-on modeling experience is useful but not required.
• Regulatory submission and health authority experience is preferred, especially at senior levels.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree