Director Pharmacometrics

Lead quantitative science that accelerates therapies from concept to approval.

R&D Partners is seeking a Director of Pharmacometrics to join a nonprofit organization dedicated to advancing collaborative scientific and regulatory innovation. This role will focus on developing actionable quantitative strategies and leading clinical pharmacology and modeling-simulation components within development plans. The position offers the opportunity to work in a public-private partnership model to accelerate the development and approval of new therapies.

Applicants must have legal authorization to work in the United States.

• Lead and manage the Pharmacometrics team within the Quantitative Medicine Program.
• Provide expertise in pharmacometrics, regulatory best practices, PK-PD data structures, and quantitative analytical methods.
• Represent Model-Informed Drug Development (MIDD) and Quantitative Medicine across cross-functional teams.
• Design, execute, and report clinical pharmacology and modeling activities.
• Develop and implement modeling and simulation plans aligned with best practices in drug development.
• Apply quantitative methods to inform dose selection, regimen optimization, and study design.
• Summarize and interpret analytical results to guide the development of quantitative drug development tools.
• Prepare scientific summaries and reports for regulatory engagement, submissions, and publications.
• Provide strategic leadership during regulatory interactions.
• Develop novel modeling methodologies and platforms to streamline development timelines.

Education:

Pharm

D or PhD required.

• Minimum 10 years of relevant experience in strategy planning and project leadership, including at least 5 years in the industry.
• Expertise in multiple modeling and simulation methodologies across therapeutic areas.
• Experience responding to regulatory agency queries.

• Strong proficiency with NONMEM and R; experience with Simcyp, Monolix, Phoenix Win Non Lin  preferred.
• Knowledge of Phase I-III clinical studies, linear and nonlinear mixed-effects modeling, parametric survival analysis, and model-based meta-analysis.

• Broad understanding of drug development functions, including PK principles, PK-PD modeling, and pharmacology.
• Strong analytical, problem-solving, and time-management skills.
• Excellent written and verbal communication skills.

$180,000 - $200,000 Per Annum

For more information, please contact Sanuel Gibbons.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.