Senior Manager/Associate Director Clinical Pharmacology

Position Overview: We are seeking an experienced Senior Manager or Associate Director to lead the clinical pharmacology strategy for antibody-drug conjugate (ADC) assets. The ideal candidate will bring expertise in pharmacokinetics, dose optimization, pharmacometrics, and drug-drug interactions. This role requires collaboration with cross-functional teams, including Clinical, Research, Regulatory, and Biometrics, to manage clinical pharmacology studies, data analysis, and regulatory submissions. Key Responsibilities: Lead and execute complex oncology clinical pharmacology studies, contributing to the development of ADC assets. Collaborate with cross-functional teams to determine dosing strategies, optimize drug schedules, and address drug-drug interaction issues. Conduct pharmacokinetic and pharmacodynamic analyses, interpreting results throughout all phases of clinical trials. Perform pharmacometric analyses to inform drug development and address key scientific questions. Lead the preparation and review of clinical pharmacology sections of study protocols, reports, investigator brochures, and regulatory submissions (INDs, NDAs, etc.), addressing regulatory inquiries as needed. Qualifications: Experience in conducting a variety of clinical studies, including first-in-human, proof-of-concept, and registrational trials. Solid understanding of drug development, with particular focus on model-informed drug development (MIDD) and the pharmaceutical R&D process. Advanced knowledge in pharmacokinetics (PK), pharmacodynamics (PD), PK/PD, Exposure-Response (ER), and quantitative systems pharmacology. Strong quantitative skills with hands-on expertise in modeling and simulation (e.g., NCA, population modeling, exposure-response analyses). Proficiency in pharmacokinetic analysis software (e.g., NONMEM, R, Simcyp, WinNonlin) and scientific graphing tools. Education and Experience: MS, PharmD, or PhD in biological or pharmaceutical sciences with a focus on pharmacology and pharmacometrics. Comprehensive understanding of clinical pharmacology study design, data analysis, and regulatory requirements. 1-5 years of experience in clinical pharmacology and pharmacometrics, with a focus on quantitative analysis. Experience in ADC development is a plus.

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