Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology. Lead the clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs. Join an innovative clinical development team dedicated to improving patient lives.

Responsibilities

• Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan; serve as Clinical Pharmacology lead for multiple programs, represent regulatory interactions, and propose innovative strategies to expedite patient access.
• Design clinical studies; provide pharmacology input on study designs across Phases 1‚Äì3 and dedicated Phase 1 pharmacology studies.
• Author and review clinical pharmacology sections for regulatory documents (IBs, INDs, NDAs, and other submissions); act as the clinical pharmacology expert in interactions with health authorities.
• Interface with cross-functional teams (clinical study teams, translational modeling and toxicology, preclinical, due diligence) to address clinical pharmacology considerations.
• Oversee or perform modeling and simulation using various tools to solve drug development questions and expedite decision making.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline, M.D. with Clinical Pharmacology expertise, or PharmD with Clinical Pharmacology fellowship; 5‚Äì9+ years of biotech/pharmaceutical drug development experience.
• Demonstrated success leading all clinical pharmacology aspects of drug development.
• Experience managing PK, PK-PD, and PK-safety analyses (non-compartmental analysis, population PK, PK-PD modeling) to support dose selection and exposure‚Äìresponse/safety analyses across development stages.
• Proficiency with WinNonlin, Monolix, NONMEM, R or equivalent modeling software.
• Strong collaboration, influencing, and conflict-resolution skills across internal and external stakeholders; experience addressing regulatory questions and preparing clinical pharmacology submissions.
• Highly motivated, decisive, proactive, resourceful, and adaptable to a rapidly growing company.

Skills

• Clinical pharmacology strategy and execution
• Pharmacokinetic/pharmacodynamic modeling and simulations
• Regulatory engagement and submissions
• Cross-functional leadership and collaboration
• Proficiency with modeling software (WinNonlin, Monolix, NONMEM, R)

Education

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline; or M.D. with Clinical Pharmacology expertise; or PharmD with Clinical Pharmacology fellowship

Additional Requirements

• Experience in oncology is preferred but not required.
• Location: Salt Lake City or New York City; hybrid work with 50% in the office.