Senior Director, Clinical Pharmacology & MIDD

Verastem Oncology; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Verastem Oncology is seeking a Lead Clinical Pharmacology and MIDD professional to guide small molecule oncology programs from first-in-human studies through registration. The role integrates nonclinical, translational, and clinical data to optimize dose, regimen, and regulatory decisions.

You will supervise PK/PD studies, biomarker workups, and biomarker-driven dosing strategies while collaborating with pharmacometricians on modeling and simulation.

Qualifications

• PhD, PharmD, MD, or equivalent advanced degree in clinical pharmacology, pharmacology, pharmaceutical sciences, or related field.
• Approximately 6+ years of relevant industry experience.
• Leadership in clinical pharmacology strategy, study design and execution, PK/PD, and dose optimization preferred in small molecule oncology.
• Strong working knowledge of MIDD, pharmacometrics, ADME/DMPK, translational PK/PD, biomarkers, and bioanalysis.

Responsibilities

• Set integrated clinical pharmacology and MIDD strategy for one or more programs including first-in-human dosing and registration planning.
• Design and oversee clinical pharmacology studies and assessments (PK/PD, biomarker sampling, DDI, formulations, special populations).
• Lead clinical pharmacology input to protocols, study execution, data review, analyses, and reports; resolve dosing and bioanalytical issues with study teams.
• Integrate PK, PD, efficacy, safety and biomarkers to optimize doses and regimens; use ADME/DMPK to address human PK and interactions.
• Define quantitative questions and partner with pharmacometricians on population PK, PK/PD, exposure-response and simulations.
• Provide scientific oversight of PK bioanalysis and guide external clinical pharmacology partners.
• Author and review content for protocols, ICH/IND submissions, reports, labeling and health authority responses.

Skills

Clinical pharmacology

MIDD

PK/PD modeling

Biomarkers

Regulatory submissions

Education

PhD/MD/PharmD or equivalent

6+ years industry experience

Job description

Verastem Oncology is seeking a Lead Clinical Pharmacology and MIDD professional to guide small molecule oncology programs from first-in-human studies through registration. The role integrates nonclinical, translational, and clinical data to optimize dose, regimen, and regulatory decisions.

You will supervise PK/PD studies, biomarker workups, and biomarker-driven dosing strategies while collaborating with pharmacometricians on modeling and simulation.