Senior Advisor, Clinical Pharmacology
Job in
Indianapolis, Marion County, Indiana, 46202, USA
Listed on 2026-10-20
Listing for:
Lilly
Full Time
position Listed on 2026-10-20
Job specializations:
-
Research/Development
-
Healthcare
Job Description & How to Apply Below
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 ORX
750) - 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 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.
** Responsibilities*
* + Provide clinical pharmacology and PK/PD input to project teams, contributing to decisions on dose, patient population, and study design
+ Conduct 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 assessment
+ Integrate 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 rationale
+ Draft 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 leadership
+ Provide day-to-day scientific oversight of CRO and vendor deliverables and take part in peer review of analyses and reports
+ Present findings to internal stakeholders and contribute to external scientific publications and presentations
** Basic Requirements*
* + PhD 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 principles
+ Hands-on proficiency with NONMEM, Phoenix Win Nonlin/NLME, Monolix, R, or similar software
+ Ability to choose an appropriate analysis, troubleshoot model problems, and clearly explain a model's assumptions and limitations
+ Working 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 translation
+ Ability to work effectively in cross-functional, matrixed environments
+ Excellent communication and stakeholder management skills
** Additional Preferences*
* + Exposure to PBPK platforms (e.g., Simcyp, Gastro Plus, PK-Sim) or QSP modeling is a plus
+…
Position Requirements
10+ Years
work experience
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