Director of Pharmacometrics
EPM Scientific representing a leading biotechnology company dedicated to transforming lives through innovative biopharmaceutical solutions. With a strong focus on neurodegenerative diseases, fertility, metabolic endocrinology, and oncology, they are committed to addressing some of the most challenging health conditions. Their mission is mission is to discover, develop, and deliver meaningful therapies that improve patient outcomes and quality of life. We leverage cutting-edge science and technology to create first-in-class and best-in-class medicines, driven by a deep understanding of patient needs.
About the Role:
We are keen to connect with a highly skilled and experienced Director of Pharmacometrics to lead our client's pharmacometrics team. The ideal candidate will be responsible for driving the strategic direction and execution of pharmacometric analyses to support drug development and regulatory submissions. This role requires a deep understanding of pharmacokinetics, pharmacodynamics, and statistical modeling, as well as strong leadership and communication skills.
Key Responsibilities:
- Lead and manage a team of pharmacometricians, providing mentorship and guidance to ensure high-quality deliverables.
- Develop and implement pharmacometric strategies to support drug development programs across various therapeutic areas.
- Collaborate with cross-functional teams, including clinical pharmacology, biostatistics, and regulatory affairs, to integrate pharmacometric analyses into overall project plans.
- Design and conduct pharmacokinetic and pharmacodynamic modeling and simulation studies to inform dose selection, trial design, and regulatory submissions.
- Prepare and present pharmacometric reports and documentation for regulatory agencies and internal stakeholders.
- Stay current with advancements in pharmacometric methodologies and software, and apply innovative approaches to enhance drug development processes.
- Represent the pharmacometrics function in meetings with external partners, regulatory agencies, and scientific conferences.
Qualifications:
- PhD in Pharmacometrics, Pharmacokinetics, Pharmacology, or a related field.
- Minimum of 10 years of experience in pharmacometrics within the pharmaceutical or biotechnology industry.
- Proven track record of successful pharmacometric analyses supporting drug development and regulatory submissions.
- Strong expertise in pharmacokinetic and pharmacodynamic modeling and simulation.
- Proficiency in pharmacometric software such as NONMEM, R, and SAS.
- Excellent leadership, communication, and interpersonal skills.
- Ability to work collaboratively in a fast-paced, dynamic environment.
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan with company match.
- Opportunities for professional development and career advancement.
- Flexible work arrangements and work-life balance initiatives.
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