Associate Director, Precision Medicine

Position Summary

Leads the development and implementation of the Model-Informed Drug Development (MIDD) strategy for drugs and other therapeutic agents in clinical development, in partnership with Clinical Pharmacology (CP) and other quantitative functions. This role places quantitative evidence at the center of development and regulatory decision-making. MIDD advances drug development by integrating diverse data through pharmacometric (PMx) models to inform development decisions and regulatory assessments. Model-Based Meta-Analysis (MBMA) provides a quantitative assessment of competitors and comparators to further refine asset strategy. MIDD informs dose and regimen selection, clinical study hypotheses, and the overall clinical data package supporting regulatory assessment of clinical pharmacology and benefit-risk. PMx analyses may also influence regulatory approval decisions and, in some cases, serve as a primary basis for approval.

Key Responsibilities

• Partner with the Clinical Pharmacology lead to develop the MIDD strategy and define the PMx plan for assigned assets.
• Lead integration across quantitative disciplines to develop and execute a coherent modeling and data strategy.
• Lead the planning, execution, interpretation, and reporting of formal PMx analyses supporting clinical study reports (CSRs), health authority submissions, and responses to regulatory questions.
• Translate complex modeling results into clear, actionable recommendations that inform asset strategy, development plans, and governance decisions.
• Serve as the MIDD subject matter expert, partnering with Clinical Pharmacology and other quantitative functions to influence development decisions for therapeutic agents.
• Advance PMx infrastructure, tools, methodologies, and ways of working.
• Lead PMx and cross-functional initiatives that strengthen quantitative decision-making across development programs.
• Provide scientific direction and oversight for PMx analyses conducted by external vendors.
• Represent the MIDD strategy and provide subject matter expertise in interactions with health authorities, helping to inform regulatory strategy.
• Collaborate with internal and external subject matter experts to advance MIDD methodologies and capabilities and introduce innovative quantitative approaches into development programs.
• Provide scientific guidance and mentorship to junior scientists in PMx and MIDD.

Qualifications & Experience

• Advanced degree in a relevant scientific or quantitative field, such as an MS, PhD, or PharmD.
• 5+ years of relevant experience with demonstrated progression in pharmacometrics and Clinical Pharmacology knowledge and increasing scientific impact.
• Demonstrated expertise in quantitative data analysis, data wrangling and transformation, visualization, population pharmacokinetic (PPK) modeling, and exposure-response (E-R) modeling.
• Proficiency with relevant modeling and programming tools, such as R, NONMEM, Monolix, Pumas, MATLAB, Python, and/or Julia.
• Working knowledge of the drug development process and the application of quantitative evidence to development and regulatory decision-making.
• Experience with mechanistic modeling approaches, such as Quantitative Systems Pharmacology (QSP) and Physiologically Based Pharmacokinetic (PBPK) modeling, is preferred.
• In-depth knowledge of current practices, methodologies, and emerging issues in pharmacometrics and Clinical Pharmacology, with a demonstrated interest in advancing the field.
• Strong written and verbal communication skills, with the ability to influence stakeholders and deliver compelling scientific presentations.
• Demonstrated ability to translate complex modeling results into clear recommendations that influence cross-functional decisions.
• Proven ability to drive scientific impact in a dynamic, collaborative, and team-oriented environment.