Associate Director, Biomarker Science

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 of Biomarker Sciences assists in the oversight of clinical and non-clinical biomarker development across Sarepta’s pipeline. This role requires expertise in biomarker discovery, development, and implementation in clinical and non-clinical stage programs with emphasis on Sarepta’s siRNA pipeline. This role requires effective communication and collaboration, working with scientists and leaders across the company, partnering with external organizations and regulatory agencies. Working in a global matrix environment to support program needs and deliver on critical milestones, this role requires strong communication of scientific concepts including the relevance and design of various bio-assays and the data generated from them. The candidate will also support the preparation of regulatory submissions and data disseminations as needed. This role will also work cross-functionally to drive data analysis efforts and lead efforts to extract critical information from existing datasets. The Opportunity to Make a Difference Primary Responsibilities Include: Assist the development and implementation of biomarker strategies consistent with the program development plans (nonclinical, translational and clinical) and regulatory strategies with emphasis on early and translational programs Collaborate with other functional leads (nonclinical, research operations, molecular biology) to support data generation efforts which support program biomarker strategies Conduct literature reviews to identify novel PK or PD biomarkers to support program needs and develop plan for implementation in non-clinical and clinical studies Perform extensive data analysis efforts to interpret non-clinical and clinical PD data and guide decision-making efforts Oversee Contract Research Organizations responsible for executing non-clinical and clinical data generation efforts including assay development and validation Represent Translational Biology on various internal functional sub-teams (clinical, non-clinical) and work cross-functionally to drive program milestones and participate in long-term planning efforts Aid in the generation of key materials for data disclosures (both internal and external) and participate in presentation efforts related to biomarker datasets and their interpretation Participate in regulatory writing efforts for translational and biomarker documents such as INDs, CTAs, and NDAs as well as assist with the completion of Requests for Information from regulatory agencies More about You Desired Education and Skills:  PhD in Pharmacology, Biochemistry, Bioinformatics or related field with 4+ years of relevant experience in the biopharmaceutical industry focusing on translational research Expertise in