Job Description
Job Overview:
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.
