Executive Director, Oncology Translational Medicine, Clinical Pharmacology Modeling and Simulation

What you'll do

• Lead clinical pharmacology and modeling/simulation strategy and support oncology drug discovery and development programs, including dosing, risk management, and registration.
• Guide clinical pharmacology study design and apply PK/PD, population PK, exposure-response, and PBPK analyses to support trials and regulatory submissions.
• Manage and develop CPMS talent, coordinate cross-functional and external contributors, and contribute to regulatory-authority meetings and dossier authoring.

What they ask for

• PhD in biological/pharmaceutical sciences or a related discipline, with an equivalent combination of experience and education potentially considered.
• Extensive drug development experience in nonclinical and clinical functions.
• At least 15 years managing matrix teams, worldwide external service providers, and consultants; at least 5 years managing talent/direct reports.
• Hands-on clinical PK and PK/PD data analysis and advanced modeling and simulation expertise; translational research and clinical pharmacology experience in ADCs, TCEs, small molecules, and antibodies.

Nice to have

• Ability to develop mechanistically sound PK-PD models and communicate modeling outcomes effectively to project teams.
• Knowledge of Oncology mechanisms, endpoints, disease understanding, and treatment approaches; familiarity with ICH/FDA/EMA guidance.

Pay

USD $0 to $0 annual base salary

Tools

Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), Modeling & Simulation, Population PK, PBPK, GxPs, INDs, IBs