Essential Functions of the Job (Key responsibilities)
- Define and execute the pharmacometric strategy for drug development programs, ensuring alignment with regulatory expectations and industry best practices.
- Provide scientific leadership in model-based approaches, including population PK/PD, exposure-response modeling, disease progression modeling, and clinical trial simulation.
- Partner with Clinical Pharmacology, Translational Medicine, Biostatistics, Regulatory, and Clinical Development teams to integrate quantitative methodologies into development strategies.
- Ensure effective resource allocation and prioritization across multiple projects in alignment with company goals.
- Champion model-informed drug development (MIDD) strategies to improve decision-making across discovery, clinical development, and regulatory submissions.
- Lead the preparation and review of pharmacometric contributions to regulatory submissions, responses, and meetings with global health authorities.
- Drive innovation by identifying emerging trends, tools, and methodologies in pharmacometrics and their application to drug development.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Ph.D. in in Pharmacometrics, Clinical Pharmacology, Applied Mathematics, Statistics, Engineering, or a related field.
- 12 years of related industry experience.
- Proven experience in leading and managing scientific teams
- Excellent communication skills and ability to effectively collaborate with cross-fucntional teams and influence decision-making process.
- Ability to balance execution of multiple tasks to accomplish program goals.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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