Senior Advisor, Clinical Pharmacology
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Job Description
Senior clinical pharmacology advisor developing PK/PD models for Centessa’s orexin medicines. Supporting dose selection, clinical studies, and regulatory filings.
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 for Phase 1–2 studies, including FIH, SAD/MAD, DDI, food effect, organ impairment, and 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, 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 including IND, CTA, and NDA/MAA
- Collaborate with DMPK, translational sciences, clinical development, bioanalysis, biostatistics, regulatory affairs, and project leadership
- Provide day-to-day scientific oversight of CRO and vendor deliverables and participate in peer review of analyses and reports
- Present findings to internal stakeholders and contribute to external scientific publications and presentations
- Report to the Executive Director, Clinical Pharmacology
- Build, evaluate, and explain quantitative models and take growing ownership of clinical pharmacology deliverables within project teams
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, including ICH M12 and ICH M15
- 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 such as Simcyp, GastroPlus, or PK-Sim, or QSP modeling, is a plus
Benefits:
- Company bonus depending, in part, on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
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