Director, Translational Pharmacokinetics - DMPK (remote)

Lilly • Indianapolis, IN

5d • $177,000 - $283,800 • Remote

About The Position

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking an experienced Director, Translational Pharmacokinetics – DMPK to provide pharmacokinetic modeling leadership for early-stage development programs across its portfolio. Centessa is a clinical-stage company developing orexin receptor 2 (OX2R) agonists for narcolepsy and potentially other sleep-wake disorders. Its lead investigational candidate, cleminorexton, is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.

The Director will develop and validate physiologically based pharmacokinetic (PBPK) models to simulate drug absorption, distribution, metabolism, and excretion (ADME), as well as drug-drug interactions (DDI). The role also develops and evolves pharmacokinetic and pharmacodynamic (PKPD) models and first-in-human (FIH) dose projections. It involves analyzing nonclinical and clinical data, preparing simulation reports, and collaborating with cross-functional teams to support drug development.

The successful candidate will integrate data from in vitro and pharmacokinetic studies to simulate ADME and DDI, optimize dosing regimens, and support regulatory submissions. The role also contributes to candidate selection, program transition from research into development, scientific recommendations to senior leadership, and mentoring junior scientists.

Requirements

• PhD, PharmD, or equivalent advanced scientific degree.
• 12 or more years of industry experience in PBPK and PKPD modeling and simulation, and FIH dose projections.
• Demonstrated experience supporting IND-enabling programs and regulatory submissions.
• Solid understanding of ADME principles.
• Proficiency with pharmacokinetic modeling software, including Simcyp, GastroPlus, Phoenix WinNonlin, and NONMEM.
• Ability to critically evaluate experimental data for use in models.
• Ability to thrive in a highly collaborative, matrixed biotechnology environment.
• Strong scientific judgment, communication, influencing, cross-functional leadership, project management, risk management, adaptability, and learning agility.
• Ability to balance scientific rigor with operational execution and provide collaborative, hands-on leadership.

Nice To Haves

• 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.

Responsibilities

• Design and implement PBPK models that accurately represent drug behavior in biological systems.
• Create or evolve PKPD models using nonclinical and clinical data.
• Support FIH dose projections for selected drug candidates progressing into the clinic.
• Integrate experimental pharmacokinetic and pharmacodynamic data to enhance model accuracy.
• Provide evidence-based simulations for regulatory decisions and submissions, including INDs, CTAs, IBs, briefing documents, regulatory responses, and health authority meeting materials.
• Participate in regulatory interactions and preparation activities.
• Collaborate with DMPK, clinical pharmacology, translation sciences, CMC, clinical development, regulatory affairs, and project management teams to support comprehensive model validation.
• Provide input into the design of in vitro and in vivo studies required for model development.
• Conduct simulations to predict DDI and optimize dosing strategies under various physiological conditions.
• Contribute to candidate selection, including supporting PK/PD models and FIH dose projections.
• Participate in development planning discussions and support transitions of programs from research into development.
• Evaluate emerging scientific and competitive landscape information.
• Present program recommendations to senior leadership and governance committees.
• Mentor junior scientists and contribute to organizational capabilities.
• Promote scientific rigor, innovation, and operational excellence across the portfolio.

Benefits

• Company bonus for eligible full-time equivalent employees, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
• Employee resource groups open to all employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree