The Associate Director, Quantitative Clinical Pharmacology provides translational, clinical pharmacology, and pharmacometrics deliverables for development assets from pre-IND to Phase III. Applies quantitative modeling methodologies including population PK, PK/PD, and disease progression modeling (multivariate statistical and empirical approaches) to integrate, analyze, and interpret diverse data sources (pharmacokinetics, pharmacodynamics including biomarker/imaging, and electronic health records). Drives and supports pharmacology and pharmacometrics activities for dose selection and characterizing interactions between drugs, patients, and biological systems to identify key predictors (highly visible, team-facing).
Responsibilities:
- Develop and execute quantitative pharmacology strategies across development through product registration.
- Lead clinical pharmacology expertise for clinical/translational development (protocol preparation, study execution, data review/analysis, study reports).
- Perform advanced quantitative pharmacology and pharmacometrics analyses (population PK, PK/PD modeling and simulation, meta-analysis, disease modeling) to support clinical decisions and dose selection.
- Serve as functional lead for global regulatory strategies and regulatory documents.
- Maintain and share leading-edge knowledge (manuscripts, scientific conferences/forums).
Qualifications:
- PhD in Pharmaceutical Sciences, mathematics/engineering, or related field; minimum 5 years in clinical pharmacology or pharmacometrics.
- Strong clinical pharmacology principles; hands-on PK/PD modeling; experience with regulatory interactions.
- Experience developing pharmacometrics/PK/PD/PBPK models; skilled with NONMEM, R, or Phoenix.
- Excellent communication, multitasking, collaboration; strong analytical and strategic thinking.
Application instructions:
- Encourage to apply if solution-oriented, comfortable with ambiguity/candor, and values kindness and integrity.
Benefits:
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Hybrid/on-site:
- Hybrid; expected to work on site in the U.S. and/or attend in-person events.