Director, Clinical Pharmacology, Modeling and Simulation (Biotech)

Location: On site in South San Francisco, California, United States

Salary: $216,414.25–$292,795.75 annual salary

Company

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

What you will do

• Develop and implement clinical pharmacology, modeling, and simulation strategies for drug development programs across therapeutic modalities.
• Design strategic clinical pharmacology and modeling plans integrated with clinical development plans.
• Design clinical pharmacology and biopharmaceutic studies and apply Model-Informed Drug Development and quantitative clinical pharmacology principles.
• Represent the department on global cross-functional drug development teams and guide programs from early- to late-stage development.
• Apply population PK/PD, PBPK, and QSP modeling to support safe and effective dosing for diverse patient populations.

Requirements

• Doctorate degree plus 4 years of Clinical Pharmacology and Modeling & Simulation experience, or master’s degree plus 8 years, or bachelor’s degree plus 10 years.
• At least 4 years of direct people management or leadership experience leading teams, projects, programs, or resource allocation; this experience may run concurrently with the technical experience.
• Experience in clinical pharmacology, modeling, and simulation, preferably in the biotechnology or pharmaceutical industry.
• Experience designing clinical pharmacology and modeling and simulation plans for new drug development across modalities.
• Experience leading clinical pharmacology and biopharmaceutic studies, including bioequivalence, biocomparability, drug-drug interaction, special population, ethnic sensitivity, ADME, and pediatric studies.
• Experience integrating study results into regulatory filings and product labels, interacting with global health authorities, authoring regulatory documents, and applying global regulatory requirements and guidance.
• Hands-on experience with quantitative PK/PD approaches, population PK/PD modeling, and PBPK modeling for clinical study design; expert knowledge of commonly used PBPK modeling software is required.
• Established track record in Model-Based Drug Development.

Nice to have

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or an equivalent professional degree such as MD or PharmD.
• 8+ years of Clinical Pharmacology, Modeling & Simulation experience in the biotechnology or pharmaceutical industry.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Full-time employment with health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions, discretionary annual bonus, and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.
• Work is on site in South San Francisco; sponsorship is not guaranteed.

Hiring process

• Applications are accepted until a sufficient number of applications are received or a candidate is selected.
• Applicants may redact age-identifying information, including age, date of birth, or dates of school attendance or graduation, from submitted materials.