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About the role
You will join an innovative and passionate clinical development team dedicated to improving the lives of patients suffering from devastating diseases. You will lead the innovative clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs.
What they're looking for
- Demonstrated success leading all clinical pharmacology related aspects of drug development
- Proficiency with WinNonlin, Monolix, NONMEM, R or other modeling software
- Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders
- Demonstrated experience responding to regulatory agency questions, preparing clinical pharmacology aspects of regulatory submissions and attending regulatory meetings
More about this role
You will join an innovative and passionate clinical development team dedicated to improving the lives of patients suffering from devastating diseases. You will lead the innovative clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs.
- Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan. You’ll be the Clinical Pharmacology lead for various programs in clinical development, the representative for regulatory interactions, and propose innovative strategies to get therapies to patients faster.
- Solve drug development questions/problems by performing and/or overseeing modeling and simulation with various tools to expedite decision making.
- Design clinical studies. You’ll provide (clinical) pharmacology input on all clinical study designs, from Phase 1-3 and dedicated Phase 1 clinical pharmacology studies.
- Author review relevant clinical pharmacology sections for regulatory documents, including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions. Act as the clinical pharmacology expert during interactions with...
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