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.
