Director, Translational PK/PD & PBPK Modeling

Eli Lilly and Company; United States; Remote; USD 177,000 - 284,000; Full time

Job summary

Centessa Pharmaceuticals, a subsidiary of Eli Lilly and Company, seeks an experienced Director of Translational Pharmacokinetics – DMPK to lead PBPK/PKPD modeling across early development programs. You will drive simulations for FIH dose projections, integrate in vitro and in vivo data, and support regulatory submissions with cross-functional collaboration.

The ideal candidate holds a PhD/PharmD or equivalent and 12+ years in PBPK/PKPD modeling, with strong regulatory submission experience and

Qualifications

• PhD, PharmD, or equivalent advanced scientific degree required.
• Extensive industry experience in PBPK and PKPD modeling with FIH dose projections.
• Proven track record supporting IND-enabling programs and regulatory submissions.

Responsibilities

• Design and implement PBPK models reflecting drug behavior in biological systems.
• Develop PKPD models using nonclinical and clinical data and support FIH dose projections.
• Provide simulations for regulatory submissions and health authority interactions.
• Collaborate with DMPK, clinical pharmacology, CMC, and clinical development teams.
• Conduct DDI and scenario analyses to optimize dosing strategies.
• Contribute to development planning and transition programs from research to development.
• Lead, mentor, and communicate scientific findings to senior leadership.

Skills

PBPK modeling

PKPD modeling

IND regulatory submissions

Data analysis & integration

Cross-functional leadership

Regulatory strategy

Education

PhD, PharmD, or equivalent advanced scientific degree

Tools

Simcyp

GastroPlus

Phoenix WinNonlin

NONMEM

Job description

Centessa Pharmaceuticals, a subsidiary of Eli Lilly and Company, seeks an experienced Director of Translational Pharmacokinetics – DMPK to lead PBPK/PKPD modeling across early development programs. You will drive simulations for FIH dose projections, integrate in vitro and in vivo data, and support regulatory submissions with cross-functional collaboration.

The ideal candidate holds a PhD/PharmD or equivalent and 12+ years in PBPK/PKPD modeling, with strong regulatory submission experience and