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 WellnessSupport for CaregiversFor a full list of our comprehensive benefits, see our website: 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 programsCollaborate with other functional leads (nonclinical, research operations, molecular biology) to support data generation efforts which support program biomarker strategiesConduct literature reviews to identify novel PK or PD biomarkers to support program needs and develop plan for implementation in non-clinical and clinical studiesPerform extensive data analysis efforts to interpret non-clinical and clinical PD data and guide decision-making effortsOversee Contract Research Organizations responsible for executing non-clinical and clinical data generation efforts including assay development and validationRepresent 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 effortsAid in the generation of key materials for data disclosures (both internal and external) and participate in presentation efforts related to biomarker datasets and their interpretationParticipate 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 agenciesMore 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 researchExpertise in neurobiology/neuromuscular biology, siRNA therapeutics, and drug development in the rare disease spaces Experience in development of bioassays, e.g., biomarkers with emphasis on protein-binding assay platformsExperience with big datasets and/or expertise in “-omics” platforms (RNASeq, Single cell, proteomics)Expertise in authoring and critically reviewing technical, clinical and regulatory documentsExperience with qualification and validation of bioanalytical assays and biomarkers under FDA, EMA, ICH GCP/GLP and other applicable guidelinesExperience in vendor management from quality, capability, data flow, interpretation, and reportingDemonstrated ability to work cross-functionally in a diverse matrixed environmentDemonstrated ability to manage multiple complex projects simultaneouslyExceptional verbal and written communication skills. Previous experience in outward facing roles is a plus. 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-HybridThis 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 $152,800 - $191,000 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.SummaryLocation: Columbus, OHType: Full time