Principal Scientist - Clinical Pharmacology, Modeling & Simulation

Role Summary

Principal Scientist - Clinical Pharmacology, Modeling & Simulation

Responsibilities

• Drive innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs.
• Apply quantitative translational and clinical pharmacology approaches (PK/PD modeling, M-PBPK, M-PBPK-PD, QSP) integrated with emerging ML and Generative AI to guide optimal clinical drug development.
• Collaborate across therapeutic areas and modalities to inform target patient populations, dosing strategies, and study designs.

Qualifications

• Basic Qualifications:
  • Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience
  • Or Master’s degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience
  • Or Bachelor’s degree and 6 years of Clinical Pharmacology and Modeling & Simulation experience
  • Or Associate’s degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience
  • Or High school diploma / GED and 12 years of Clinical Pharmacology and Modeling & Simulation experience
• Preferred Qualifications:
  • PhD in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent professional degrees (MD, PharmD).
  • 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
  • Hands-on experience with PK/PD, M-PBPK, M-PBPK-PD, and QSP modeling; expert software knowledge.
  • Established track record of Model Based Drug Development (MIDD).
  • Regulatory experience and knowledge of global regulatory requirements; ability to interact with health authorities and author regulatory documents.
  • Experience leading design and implementation of clinical pharmacology and biopharmaceutic studies and integrating results into regulatory filings and product labels.

Skills

• Quantitative Clinical Pharmacology approaches with focus on PK/PD, M-PBPK, M-PBPK-PD, and QSP modeling
• Software proficiency for PK/PD, M-PBPK, M-PBPK-PD, and QSP modeling
• Leadership and collaboration across cross-functional teams

Education

• Doctorate or Master’s or Bachelor’s or Associate’s or high school with applicable experience as listed in Basic Qualifications
• PhD preferred for advanced modeling domains

Additional Requirements

• Willingness to engage with diverse therapeutic areas including oncology, rare diseases, obesity, and cardiovascular disease
• Ability to work in a fast-paced, collaborative environment and to communicate complex modeling results to non-specialists