Principal Investigator / Sr. Principal Investigator, Clinical Pharmacology & Pharmacometrics (PBPK)

Location: Wilmington, Delaware, United States

Company

hirify.global is a global biopharmaceutical company developing proprietary therapeutics in Hematology, Oncology, Inflammation, and Autoimmunity.

What you will do

• Develop and implement clinical pharmacology strategies across programs, indications, and Phase I–III studies.
• Build, verify, qualify, and apply PBPK and mechanistic models using Simcyp, GastroPlus, PK-Sim, or equivalent platforms.
• Integrate in vitro ADME, physicochemical, preclinical, and clinical data to support drug disposition and development decisions.
• Guide interpretation of PPK, exposure–response, and other quantitative pharmacology analyses for MIDD-based decisions and dose selection.
• Support study design, formulation optimization, population simulations, pediatric extrapolation, DDI predictions, and organ impairment strategies.
• Present recommendations to project teams and senior leadership and author PBPK reports, regulatory documents, briefing books, and health-authority responses.

Requirements

• Ph.D. or MD with 3–10 or more years of experience in a relevant discipline.
• Experience supporting clinical development programs with clinical PK and clinical pharmacology analyses.
• Strong competency with PBPK modeling and simulation software such as GastroPlus, Simcyp, PK-Sim, R, and Matlab/SimBiology.
• Knowledge of DDI, DMPK, in vitro ADME, pharmacokinetics, transporters, translational modeling, biotransformation, and biomarker strategy.
• Ability to collaborate across clinical development, DMPK, pharmaceutical sciences, translational medicine, regulatory affairs, and related functions.
• Ability to prioritize multiple projects, meet deadlines, and communicate scientific recommendations effectively.

Nice to have

• Hands-on industry experience in PBPK modeling and simulation and knowledge of regulatory expectations.
• Experience with PPK, exposure–response, or PBPK analyses and reporting, including NONMEM, R, Simcyp, or GastroPlus.
• Experience interacting with FDA, EMA, PMDA, or other regulatory agencies regarding PBPK analyses.
• Experience with model-informed drug development and a demonstrated publication record, including lead or senior author contributions.

Culture & Benefits

• Cross-functional collaboration across discovery, development, clinical, regulatory, and medical teams.
• Opportunity to influence drug development decisions from IND through Phase IV.
• Work includes scientific publications, internal presentations, external conferences, and collaboration with global program teams.