Senior Director, Quantitative & Clinical Pharmacology

Benefits

Additional Information

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 This leadership role will be developing and executing translational, clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development. Key areas of emphasis will include but are not limited to clinical dose selection and refinement across all phases of clinical development, FIH and clinical pharmacology study designs, development and hands-on application of MIDD using population and statistically based methodologies, as well as mechanistic and translational PK/PD approaches. This role will manage a team of scientists and serve as a SME on programs. The Opportunity to Make a Difference Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred) Represent as therapeutic lead (siRNA or oligonucleotide experience is preferred) and SME in clinical pharmacology strategies, clinical study protocol preparation, study execution, data review/analysis, and study reports Lead the development and execution of translational and mechanistically based PK/PD modeling to enable identification of FIH dose, early characterization of efficacy and safety using biomarkers and disease animal models Lead and execute pharmacometrics strategies across all stages of drug development including population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development Support non-clinical PK/PD, ADME and DMPK evaluations including strategy development, study design and execution, data analyses to inform lead optimization, candidate selection and nonclinical drug development Represent as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience is a must) Supervise, mentor and develop a team of high-performing scientists Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications Encompass leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts Advocate scientific leadership at external conferences and scientific community. More about You PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field with ≥ 10 years of experience working in biotech or pharmaceutical industry Expertise in clinical pharmacology and pharmacometrics principles, strong hands-on experience in modeling and data analytics, and proven success in regulatory interactions from IND through registration siRNA and/or Oligonucleotide experience is highly preferred Demonstrated success in leading and building high-performing teams, with a strong commitment to people development Excellent communication, multitasking, and collaboration skills in cross-functional and matrixed team environments 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 $222,400 - $278,000 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 pa