Senior Advisor, Clinical Pharmacology & PK/PD Modeling

100 Eli Lilly and Company; United States; Remote; USD 161,000 - 264,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Well-being benefits

Job summary

Centessa Pharmaceuticals, a clinical-stage company and subsidiary of Eli Lilly, seeks a Senior Advisor, Clinical Pharmacology to bring deep PK/PD and pharmacometrics expertise to early- and mid-stage programs.

You will build, evaluate, and explain quantitative models, translate nonclinical data into clinical decisions, and drive pharmacology deliverables within project teams across DMPK, translational sciences, and regulatory affairs.

Qualifications

• 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.

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

Skills

PK/PD theory

ADME

DDI mechanisms

MIDD

NONMEM

Phoenix WinNonlin

NLME

R

Cross-functional work

Communication skills

Education

PhD or PharmD in Clinical Pharmacology or related

Tools

NONMEM

Phoenix WinNonlin

Monolix

R

Job description

Centessa Pharmaceuticals, a clinical-stage company and subsidiary of Eli Lilly, seeks a Senior Advisor, Clinical Pharmacology to bring deep PK/PD and pharmacometrics expertise to early- and mid-stage programs.

You will build, evaluate, and explain quantitative models, translate nonclinical data into clinical decisions, and drive pharmacology deliverables within project teams across DMPK, translational sciences, and regulatory affairs.