Principal Scientist - Clinical Pharmacology Modeling and Simulation (Biotech)

Location: Thousand Oaks, California, United States

Salary: USD 147,696–199,824 annually

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead clinical pharmacology strategy for one or more development programs from early clinical development through registration and post-approval activities.
• Develop integrated plans addressing PK, PD, exposure-response, dose and regimen selection, drug-drug interactions, special populations, ethnic sensitivity, and formulation changes.
• Design and oversee first-in-human, drug-drug interaction, ADME, organ impairment, bioavailability/bioequivalence, pediatric, and other clinical pharmacology studies.
• Lead first-in-human starting-dose and escalation decisions by integrating nonclinical pharmacology, toxicology, PK/PD, biomarkers, and predicted human exposure.
• Plan, interpret, and present noncompartmental, population PK, exposure-response, and other quantitative analyses supporting development and regulatory decisions.
• Provide modeling and simulation oversight and contribute to clinical development plans, regulatory submissions, health-authority interactions, and product labeling.

Requirements

• PhD, PharmD, or MD with relevant postdoctoral experience and 2 years of related experience; alternatively, a master’s degree with 5 years or a bachelor’s degree with 7 years of relevant experience.
• Advanced degree preferred in pharmaceutical sciences, pharmacology, chemical engineering, or a related quantitative discipline.
• 5+ years of clinical pharmacology and modeling and simulation experience in the biotechnology or pharmaceutical industry preferred.
• Experience with population PK, PK/PD, PBPK, and QSP modeling and quantitative clinical pharmacology approaches.
• Experience designing and interpreting clinical pharmacology studies and supporting regulatory submissions, health-authority interactions, and product labeling.
• Strong scientific judgment, leadership through influence, cross-functional collaboration, and written and verbal communication skills.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable to the designated work location.