Senior Advisor, Clinical Pharmacology (remote)
Eli Lilly and Company
Summary
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 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.
Job description
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 WinNonlin/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, GastroPlus, PK-Sim) or QSP modeling is a plus
- Intrinsically 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
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 WinNonlin/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
- Exposure to PBPK platforms (e.g., Simcyp, GastroPlus, PK-Sim) or QSP modeling is a plus
Benefits
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Employee Assistance Program
- Fitness Benefits
- Employee Clubs and Activities
- Company Bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.