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Senior Advisor, Clinical Pharmacology

Eli Lilly

Senior Advisor, Clinical PharmacologyAt 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.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 is seeking a Senior Advisor, Clinical Pharmacology (equivalent to Associate Director) to bring strong technical depth in PK/PD and pharmacometrics to our clinical-stage development. Reporting to the Executive Director, Clinical Pharmacology, you will be a hands-on scientist who builds, evaluates, and explains quantitative models, translates nonclinical and biomarker data into clinical decisions, and takes growing ownership of clinical pharmacology deliverables within project teams.ResponsibilitiesProvide clinical pharmacology and PK/PD input to project teams, contributing to decisions on dose, patient population, and study designConduct and interpret noncompartmental and population PK analyses, including structural model development, covariate evaluation, and model diagnostics, for Phase 1–2 studies (FIH, SAD/MAD, DDI, food effect, organ impairment, patient studies)Build and apply exposure–response and PK/PD analyses and PBPK models to support dose selection and drug–drug interaction risk assessmentIntegrate nonclinical PK/PD, in vitro ADME (CYP phenotyping, inhibition and induction, transporter data), and biomarker data to support human PK and dose projections, interspecies scaling, and first-in-human rationaleDraft PK/PD sections of clinical development plans, protocols, analysis plans, investigator brochures, study reports, and regulatory documents (IND, CTA, NDA/MAA)Collaborate closely with experts across DMPK, translational sciences, clinical development, bioanalysis, biostatistics, regulatory affairs, and project leadershipProvide day-to-day scientific oversight of CRO and vendor deliverables and take part in peer review of analyses and reportsPresent findings to internal stakeholders and contribute to external scientific publications and presentationsBasic RequirementsPhD or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline, or a graduate degree in these areas with a strong demonstrated work history.3+ years of industry experience in clinical pharmacology or pharmacometrics within biotech, pharmaceutical, or drug development environments (relevant postdoctoral experience considered)Solid working knowledge of PK/PD theory, ADME, DDI mechanisms including in vitro-to-clinical translation, and MIDD principlesHands-on proficiency with NONMEM, Phoenix WinNonlin/NLME, Monolix, R, or similar softwareAbility to choose an appropriate analysis, troubleshoot model problems, and clearly explain a model's assumptions and limitationsWorking knowledge of FDA, EMA, and ICH guidance relevant to clinical pharmacology (e.g., ICH M12 on drug interaction studies, ICH M15 on MIDD)Interest in translational medicine, including target engagement, biomarkers, and nonclinical-to-clinical translationAbility to work effectively in cross-functional, matrixed environmentsExcellent communication and stakeholder management skillsAdditional PreferencesExposure to PBPK platforms (e.g., Simcyp, GastroPlus, PK-Sim) or QSP modeling is a plusIntrinsically curious and deeply passionate about the work we do.Embrace ambiguity and push for new practices and technologies.Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn't clear.Leverage technical depth and a growth mindset to make impact; imagine what's possible and pursue it with intention and energy.Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital.

Vacancy posted 1 day ago
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