Director, Pharmacometrics, Clinical Pharmacology

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Pharmacometrics, Clinical Pharmacology based in United States.

This role sits at the intersection of quantitative science and clinical development strategy, driving how data informs critical decisions across drug development programs. You will lead the design and execution of modeling and simulation approaches that shape dose selection, trial design, and regulatory strategy from early to late-stage development. Operating in a highly collaborative, cross-functional environment, you will serve as a key scientific authority within Model-Informed Drug Development (MIDD). Your work will directly influence clinical and regulatory outcomes for therapies targeting rare diseases. This is a hands-on leadership role combining scientific depth, strategic thinking, and program impact. You will partner closely with clinical, regulatory, and development teams to ensure robust, data-driven decision-making across the portfolio.

In this role, you will lead the development and execution of pharmacometrics strategies across clinical programs, ensuring the integration of quantitative methods into all phases of drug development. You will act as a subject matter expert in modeling and simulation, shaping key program decisions and regulatory strategies while supporting Model-Informed Drug Development (MIDD) initiatives.

• Develop and execute end-to-end modeling and simulation strategies across early- and late-stage clinical development programs.
• Serve as the pharmacometrics expert within cross-functional development teams, guiding scientific and strategic decision-making.
• Deliver timely quantitative insights to support critical development milestones and go/no-go decisions.
• Lead PK/PD, population PK, exposure-response, and disease progression modeling activities using state-of-the-art approaches.
• Define pharmacometric strategies for regulatory submissions, including dose justification and trial design support.
• Collaborate on integrating modeling outputs into broader clinical, regulatory, and development plans.
• Guide exploratory and advanced modeling approaches, including QSP and empirical frameworks linking PK, biomarkers, and outcomes.

Requirements:

This position requires strong expertise in quantitative pharmacology, with deep experience applying modeling and simulation methodologies in pharmaceutical or biotech environments. You will bring both technical excellence and the ability to translate complex analyses into actionable development insights.

• PhD or PharmD in Pharmaceutical Sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering, or related field.
• 6+ years of relevant industry experience in pharmacometrics and model-based drug development.
• Strong expertise in NLME methods, population PK/PD modeling, exposure-response analysis, and clinical trial simulation.
• Hands-on experience with tools such as NONMEM and R strongly preferred.
• Solid understanding of clinical pharmacology principles and therapeutic areas relevant to drug development.
• Experience integrating MIDD approaches across all stages of development and regulatory interactions.
• Strong analytical thinking, scientific reasoning, and ability to interpret complex datasets.
• Excellent communication skills with the ability to explain technical concepts to diverse stakeholders.
• Ability to manage multiple priorities in a fast-paced, matrixed environment with strong independence and ownership.

Benefits:

• Competitive base salary with short-term and long-term incentive compensation (including equity)
• Comprehensive medical, dental, and vision insurance for employees and eligible dependents
• Retirement savings plan with employer matching contributions
• Generous paid time off and flexible vacation policies
• Life insurance, disability coverage, and financial protection benefits
• Wellness programs and employee support resources
• Opportunities to work on high-impact rare disease development programs in a collaborative environment
• Flexible work arrangements with remote-based structure (with occasional travel as needed)