Associate Director, Quantitative Clinical Pharmacology

Sarepta Therapeutics•Cambridge, MA

3d•Hybrid

About The Position

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. 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 The Importance of the Role 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. The Opportunity to Make a Difference 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. More about You 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 What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid Blank This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

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

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