Associate Director, Quantitative Clinical Pharmacology

Sarepta Therapeutics • Cambridge, MA

13h • Hybrid

About The Position

The Associate Director, Quantitative Clinical Pharmacology is responsible for providing translational, clinical pharmacology, and pharmacometrics deliverables for development assets from pre-IND to Phase III. This incumbent will apply quantitative modeling methodologies inclusive of population PK, PKPD, disease progression modeling using multivariate statistical and empirical approaches to integrate, analyze and interpret diverse data sources (e.g., pharmacokinetics, pharmacodynamics including biomarker & imaging, electronic health records). The Associate Director will drive and support pharmacology and pharmacometrics activities involved for dose selection and characterizing the interactions between drugs, patients, and biological systems to identify key predictors. This is a highly visible and team-facing role.

Requirements

• PhD in Pharmaceutical Sciences, mathematics/engineering or related field with minimum of 5 years of experience working in clinical pharmacology or pharmacometrics
• Strong understanding of clinical pharmacology principles, strong hands-on experience with PK/PD modeling analysis, and experience in regulatory interactions
• Experience in developing advanced pharmacometrics, PK/PD, PBPK models to aid in research and development decision making.
• Skilled in using pharmacometrics analysis software (e.g., NONMEM, R, Phoenix).
• Excellent communication, multitasking, and collaboration skills
• Strong analytical skills and strategic thinking
• Candidates must be authorized to work in the U.S.

Responsibilities

• Drives the development and execution of quantitative pharmacology strategies across all stages of development through product registration
• Leads clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, study reports
• Responsible for advanced quantitative pharmacology and pharmacometrics analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to yield high value PK/PD support for critical clinical decisions and dose selection
• Serves as functional lead for global regulatory strategies and regulatory documents
• Maintains leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publishes manuscripts, presents at scientific conferences and scientific forums

Benefits

• We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers
• For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
• Sarepta Therapeutics offers a competitive compensation and benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree