Pharmacometrics Director

Step into a role where science meets strategy and your expertise shapes the future of drug development. As a Director, Pharmacometrician, you’ll lead high-impact modeling and simulation efforts within a dynamic Clinical Pharmacology, Modeling and Simulation (CPMS) environment. You’ll guide teams, mentor pharmacometricians, and provide strategic insight to clients at key development milestones. This role also offers the opportunity to represent clients in interactions with regulatory agencies. If you thrive on collaboration and solving complex scientific challenges, this is your chance to make a meaningful impact.

About the role

This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy. You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions. In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement.

Your main responsibilities will include but not limited to:

• Lead and conduct population PK analyses using advanced modeling tools and methodologies
• Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
• Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies  
• Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
• Author and review PK reports and clinical pharmacology sections of regulatory documents
• Represent clients in regulatory interactions and contribute to business development and relationship management

Requirements

About You

If you are a driven clinical pharmacology professional with 6–10 years of experience in drug development and pharmacometrics and you bring sharp analytical thinking and expertise in tools like NONMEM, Pirana, and R to deliver high-impact insights while being client-focused and a natural leader who thrives in fast-paced environments, combining strategic thinking, strong communication, and business acumen to build relationships and drive results, this role is for you.

To be successful we are looking for the following traits and behaviors:

• Life science, healthcare and/or business degree 
• Minimum 10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics 
• Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions