Manager, Clinical Development – PBPK

Overview

Manager, Clinical Development – PBPK is a specialized role within the Clinical Development team focused on physiology-based pharmacokinetic (PBPK) modeling for early phase clinical programs and translational preclinical work.

What you'll do

• Independently perform non-compartmental PK analysis to guide study design elements and model building.
• Meta-analyze literature and build PBPK models to guide formulation development and dissolution profiles.
• Run PBPK/PK-based simulations to guide sampling matrices, sample collection, and study design.
• Communicate and present study results internally and externally.
• Oversee/review external PBPK/PK-related work and guide as needed.
• Contribute to clinical document development, review, and approval (e.g., pre-IND/IND and clinical modules).

What you'll need

• Minimum 5+ years in drug development with at least 3 years in early phase clinical development.
• Hands-on modeling and simulation experience is preferred/required as stated (“with hands-on modeling & simulation experience preferred”).
• Must have ICH GCP requirement for regulatory model-informed drug development.
• Working knowledge of biostatistics and pharmacokinetics.
• Proven experience using PK-Sim, GastroPlus, Winnonlin, or similar PK software.
• Strong organizational and communication skills for cross-functional teamwork.

Nice to have

• M.Pharm/Pharm.D/Ph.D preferred in pharmaceutics, pharmacoinformatics, or pharmacology.

Details

• Location: Hyderabad, IN.