Associate Director, Pharmacometrics

Role Summary

Associate Director, Pharmacometrics responsible for transforming non-clinical and clinical data into analyses that inform model-informed drug development (MIDD) of innovative drugs. Collaborates with cross-functional teams to develop models quantifying exposure–response relationships to guide dose selection and trial design. Works independently to support design, execution, and analysis of data from clinical studies, and contributes to publications and conferences.

Responsibilities

• Apply quantitative pharmacology and pharmacometrics methods within assigned programs to provide high-value support for critical decisions in development candidate progression
• Develop and execute modeling & simulation (M&S) plans to support candidate drug development
• Independently develop and report population PK, PK/PD, and disease progression analyses
• Incorporate and develop methodologies informed by relevant scientific literature
• Perform meta-analysis using proprietary and/or literature data
• Apply FDA and ICH guidelines in the design of clinical studies and drug development strategy
• Author M&S sections for regulatory interactions and responses
• Maintain scientific awareness in quantitative pharmacology and pharmacometrics; prepare abstracts and manuscripts for publication
• Strengthen pharmacometrics capabilities by evaluating new M&S tools and organizing trainings as appropriate
• Contribute to a high-growth, transformational company with a culture described as Bold, Relentless, Curious, and Collaborative

Qualifications

• PhD with focus in pharmacokinetics, pharmacology, pharmaceutics or related field; minimum 8+ years of drug development experience post-PhD
• Hands-on proficiency with pharmacometrics tools (NONMEM, R, Julia, Monolix, Phoenix, etc.)
• Deep understanding of pharmacometrics principles and M&S strategy incorporation

Preferred Qualifications

• Drug development experience in oncology and rare diseases; expertise in immune therapeutics and/or infectious diseases is a plus
• Platform expertise in mRNA therapeutics or experience with biologics/new modalities
• Familiarity with binary/categorical data analysis, time-to-event models, Poisson models, logistic regression, MCMC and Bayesian methods as applied to exposure‚Äìresponse analyses, meta-analyses, and population PK/PKPD analyses
• Track record of regulatory filings (NDA/BLA) and responding to regulatory inquiries; knowledge of global regulatory guidance on quantitative analysis
• Ability to develop and deliver clear presentations for internal and external meetings
• Curiosity to explore new paths for MIDD; collaborative with multifunctional teams; relentless in pursuing outcomes
• Strong publication record in pharmacometrics
• Effective teamwork, influence, problem resolution across internal and external project teams
• Excellent interpersonal, verbal, and written communication in a highly matrixed environment
• Desire to contribute to a high-growth, transformational company with a Bold, Relentless, Curious, and Collaborative culture