Vice President, Translational Medicine & Clinical Pharmacology

Position Summary

• The Vice President, Translational Medicine & Clinical Pharmacology is a senior scientific leader integrating translational medicine, clinical pharmacology, DMPK (drug metabolism/pharmacokinetics), bioanalysis, toxicology, and PK/PD & biomarker strategy across the portfolio.
• Reporting to the Chief Medical Officer, provides strategic and functional leadership from development candidate selection and IND-enabling through clinical development, regulatory submission, and life-cycle management.

Essential Duties and Responsibilities

• Define and lead integrated translational medicine and clinical pharmacology strategy across the portfolio.
• Lead clinical pharmacology strategy and development plans (ADME, DDIs, PK/PD, exposure-response, bioavailability/bioequivalence).
• Oversee DMPK activities (drug metabolism, pharmacokinetics, bioanalysis) supporting discovery through regulatory filings.
• Use translational/quantitative pharmacology (population PK, PK/PD, pharmacometrics, modeling/simulation) to inform first-in-human strategy, dose escalation/optimization, go/no-go, and late-stage dose justification.
• Develop translational and biomarker strategies (target-engagement, PD, predictive/prognostic/safety biomarkers) for indication selection, patient enrichment, and proof-of-concept.
• Partner cross-functionally to translate preclinical biology into executable clinical development strategies.
• Provide scientific leadership for protocol/IB/clinical study report/IND-CTA/NDA-BLA-MAA content; interact with health authorities.
• Evaluate/manage external partners (labs, consultants, academic collaborators) with GxP compliance.
• Build and lead the team; manage resources, budgets, priorities.

Knowledge and Skill Requirements

• Advanced degree (PhD, PharmD, MD, or equivalent); PhD or PharmD strongly preferred.
• Typically 15+ years biopharmaceutical industry experience in drug development, translational medicine, DMPK and/or clinical pharmacology; senior leadership and people management.
• Deep expertise in clinical pharmacology, PK/PD, ADME, bioanalysis, DDIs, exposure-response, and quantitative dose-selection/optimization.
• Experience integrating preclinical pharmacology and translational biomarkers/PK/PD to advance programs from IND through proof-of-concept and later stages.
• Strong biomarker strategy/assay development knowledge; patient-selection/precision-medicine preferred.
• Extensive regulatory submission and health authority interaction experience; strong knowledge of FDA, ICH, GLP, GCP.
• Strong cross-functional leadership and executive communication.

Compensation and Benefits

• Anticipated salary range: $306,000 to $365,000.
• Eligible for annual bonus and equity incentive awards (not commission-based).
• Comprehensive benefits: medical/dental/vision, life/disability, flexible spending accounts, 401(k), paid time off and holidays.