Director of DMPK
2 weeks ago
Overview:
We are seeking a highly skilled professional to provide comprehensive guidance on clinical pharmacology initiatives that support drug discovery and development. This role involves authoring clinical protocols, analyzing data (exposure, efficacy, safety), and contributing to the development and registration of new products.
Key Responsibilities:
- Apply advanced pharmacometric methodologies to support drug discovery, development, and regulatory decisions.
- Conduct model-based analyses, including population pharmacokinetics, pharmacokinetic-pharmacodynamic modeling, exposure-response analyses, quantitative systems pharmacology, and physiological-based pharmacokinetic modeling.
- Develop and implement customized clinical pharmacology and DMPK plans.
- Write, review, and edit regulatory documents (e.g., INDs, NDAs, IBs) and respond to regulatory inquiries.
- Ensure timely and accurate execution of clinical pharmacology studies and programs within agreed timelines and budgets.
- Lead the writing of scientific publications, including abstracts, posters, oral presentations, and manuscripts.
- Manage relationships with CROs to ensure compliance with protocols, quality standards, and timelines.
Requirements:
- Ph.D. or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology, Chemistry, or a related field, with a minimum of 10 years of industry experience.
- Extensive experience in pharmacometrics analysis with hands-on expertise in study design, data analysis, and modeling-simulation.
- Proficiency in modeling software (e.g., Phoenix WinNonlin, NONMEM, R, SAS).
- Excellent communication and teamwork skills to effectively collaborate with external and internal teams.
- Strong knowledge of model-informed drug development, DMPK-Clinical Pharmacology concepts, and regulatory requirements.
- Experience in managing external resources, including CROs and consultants.
- Ability to handle multiple tasks in a fast-paced environment while maintaining a positive attitude and strong work ethic.
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