Associate Director, Clinical Pharmacology & DMPK (Pharmacometrics)

Location: Palo Alto, California, United States

Salary: $174,000–$204,000 USD per year, with potential bonus, stock, benefits, and other variable compensation.

Company

hirify.global is a biopharmaceutical oncology company developing investigational therapies and conducting global Phase 3 studies in non-small cell lung cancer and colorectal cancer.

What you will do

• Serve as a pharmacometrics subject matter expert on cross-functional clinical development teams and contribute to clinical pharmacology and model-informed drug development strategies.
• Design, conduct, interpret, and report NCA, population PK, PK/PD, model-based meta-analysis, and exposure-response analyses.
• Develop models and simulations supporting clinical trial design, dose selection and optimization, benefit-risk evaluation, covariate assessment, and program decisions.
• Collaborate with Clinical Development, Biostatistics, Statistical Programming, Data Management, Translational Medicine, and Regulatory Affairs.
• Develop pharmacometric analysis plans and draft analysis reports and regulatory submission sections, including quantitative contributions to health authority responses.
• Provide technical oversight of external pharmacometrics vendors and consultants, including review of plans, datasets, models, outputs, and reports.

Requirements

• Ph.D., Pharm.D., or equivalent advanced degree in pharmacometrics, pharmacokinetics, pharmaceutical sciences, pharmacology, biomedical engineering, applied mathematics/statistics, or a related discipline with 3+ years of relevant pharmaceutical or biotechnology industry experience; or an M.S. with 5+ years of relevant experience.
• Hands-on quantitative modeling experience and proficiency with NONMEM/PsN, R, and Phoenix WinNonlin or comparable tools.
• Experience applying modeling and simulation to dose selection or optimization, clinical trial design, benefit-risk assessment, and development decision-making.
• Experience drafting pharmacometric and clinical pharmacology analysis reports and supporting regulatory submissions.
• Working knowledge of drug development and FDA, ICH, and other regulatory expectations for clinical pharmacology and pharmacometrics.
• Strong scientific and technical writing, communication, problem-solving, and project management skills, with the ability to work effectively on multidisciplinary teams.

Nice to have

• Experience contributing to responses to regulatory agency questions.
• Experience managing external pharmacometrics vendors, CROs, or consultants.

Culture & Benefits

• Mission-driven oncology organization focused on improving quality and duration of life and addressing serious unmet medical needs.
• Values include integrity, excellence, purposeful urgency, collaboration, and commitment to people.
• Total compensation may include bonus, stock, benefits, and other applicable variable compensation.
• Summit is an Equal Opportunity Employer.