Senior Advisor, Clinical Pharmacology

100 Eli Lilly and Company; United States; À distance; USD 161 000 - 264 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Well-being benefits

Résumé du poste

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.

Responsabilités

• 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

Connaissances

PK/PD theory

ADME

DDI mechanisms

MIDD

NONMEM

Phoenix WinNonlin

NLME

R

Cross-functional work

Communication skills

Formation

PhD or PharmD in Clinical Pharmacology or related

Outils

NONMEM

Phoenix WinNonlin

Monolix

R

Description du poste

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.

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.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is $153,000 - $268,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly