Senior Advisor, Clinical Pharmacology

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