Director, Translational Pharmacokinetics - DMPK

Organization and Position Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa is seeking an experienced Director, Translational Pharmacokinetics – DMPK to provide pharmacokinetic modeling leadership for early-stage development programs across the company's portfolio.

In this role you will develop and validate physiologically based pharmacokinetic (PBPK) models to simulate drug absorption, distribution, metabolism, and excretion (ADME) and drug-drug interactions (DDI) in the body. Furthermore, you will develop and evolve pharmacokinetic and pharmacodynamic (PKPD) models and first-in-human (FIH) dose projections. The responsibilities include analyzing nonclinical and clinical data, preparing simulation reports, and collaborating with cross-functional teams to support drug development processes.

Responsibilities

Model Development

• Design and implement PBPK models that accurately represent drug behavior in biological systems
• Create and/or evolve PKPD models with nonclinical and clinical data
• Support FIH dose projection for selected drug candidates progressing into the clinic

Data Integration

• Integrate diverse experimental data, including pharmacokinetics and pharmacodynamics, to enhance model accuracy

Regulatory Support

• Provide evidence-based simulations to support regulatory decisions and submissions including INDs, CTAs, IBs, briefing documents, regulatory responses, and health authority meeting materials
• Participate in regulatory interactions and preparation activities

Collaboration

• Work closely with cross-functional teams, including DMPK, clinical pharmacology, translation sciences, CMC, clinical development, regulatory affairs, and project management, to ensure comprehensive model validation
• Provide input into the design of in vitro and in vivo studies required for model development

Scenario Analysis

• Conduct simulations to predict DDI
• Optimize dosing strategies under various physiological conditions

Pipeline Progression

• Contribute to candidate selection activities including the support of PK/PD models and FIH dose projections
• Participate in development planning discussions and support transition of programs from research into development

Scientific Leadership

• Evaluate emerging scientific and competitive landscape information
• Present program recommendations to senior leadership and governance committees
• Mentor junior scientists and contribute to development of organizational capabilities
• Promote scientific rigor, innovation, and operational excellence across the portfolio

Qualifications

• PhD, PharmD, or equivalent advanced scientific degree
• 12+ years of industry experience in modeling and simulation of PBPK and PKPD models, and FIH dose projections
• Demonstrated experience supporting IND-enabling programs and regulatory submissions
• A solid understanding of the principals of ADME
• Proficiency in various pharmacokinetic modeling software platforms, including Simcyp, GastroPlus, Phoenix WinNonlin, and NONMEM
• Ability to critically evaluate experimental data for input into models
• Ability to thrive within a highly collaborative, matrixed biotechnology environment

Additional Preferences

• Experience supporting CNS, neuroscience, rare disease, or sleep-wake disorder programs
• Familiarity with FDA, EMA, and ICH regulatory requirements
• Experience advancing programs from candidate selection through clinical development
• Experience managing CRO networks and outsourced development activities

Core Competencies

• Strategic thinker with strong scientific judgment
• Excellent communication and influencing skills
• Cross-functional leadership
• Strong project and risk management capabilities
• Ability to balance scientific rigor with operational execution
• Collaborative, hands-on leadership style
• Adaptability and learning agility