Director, Translational Pharmacokinetics - DMPK

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 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’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026. Centessa Pharmaceuticals 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. The ideal candidate has a strong foundation in pharmacokinetics, mathematical modeling, and effective communication to accurately predict drug behavior and collaborate with multidisciplinary teams. You will play a critical role in integrating data from in vitro and pharmacokinetic studies to simulate ADME and DDI, which aids in optimizing dosing regimens and supporting regulatory submissions. 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring