Manager, Translational Biology

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

Sarepta Therapeutics is seeking a highly motivated and experienced individual in the field of neuromuscular biology, siRNA and genetic therapies drug development. The Manager / Scientist of Translational Biology will be pivotal in overseeing and advancing biomarker strategies including PK and PD. The candidate will lead cross-functional Biomarker team to drive identification of biomarkers, technology and CRO selection, methods development and validation in line with the context of use by collaboration with teams internally or vendor management, sample testing activities across multiple clinical and non clinical studies, and analysis of biomarker data. The candidate will be pivotal in supporting assessments of target engagement, pathway modulations and disease modification to guide internal and health authority’s decision making.

This person will author and review methods, SOPs, protocols, reports, and contribute to regulatory documents. This position will be a key technical point of contact for Research Sciences, Clinical Development, Clinical Operations, Research Operations, Data Management, Biostatistics, Quantitative and Clinical Pharmacology, and vendors. Additional responsibilities include contributing to vendor audit, inspection readiness, and health authorities engagement activities as an SME. The Manage / Scientist of Translational Biology will be instrumental in driving our innovative research initiatives forward.

• Using molecular biology and data analysis knowledge to develop and implement biomarker strategies in support of internal and health authorities’ decision making. Specifically, drive identification of biomarkers, technology and CRO selection and management, methods development and validation in line with the context of use, sample testing activities across multiple clinical and non clinical studies, and analysis of biomarker data.
• Bench side execution and management of optimizations, qualifications, validations, and sample testing with an emphasis on molecular methods e.g. PCR, Western blot, ELISA and high-sensitivity ELISA based platforms.
• Flexibility and adaptability to additional projects and responsibilities as assigned to support the department's overall goals.

• Manage projects and timelines, organize/track complex information, prioritize accordingly, and have the ability to adjust to shifting priorities and demanding timelines when necessary quickly.
• Identify and implement processes improvements to foster cross-functional collaboration, enhance efficiency and compliance within Sarepta.
• Support cross-functional data collection compilation for both non-clinical and clinical programs.

• Contribute to cross-functional Biomarker team designed to refine and execute program PK, PD and biomarker strategy supporting program development plan and regulatory strategy
• Identity, build relationships and lead CRO teams dedicated to assay method development, bioanalytical method validation, and execution of non-clinical and clinical sample testing.
• Foster a collaborative and growth-oriented internal team culture.

• Collaborate closely with Bioanalytical leads, Clinical Development and Clinical Operations to integrate data analytics into clinical protocols and reports seamlessly.
• Develop and execute data transfer in coordination with Clinical Operations, Data Management, Research Operations and CROs.

• Ensure compliance with GDP, GCP, GLP, bioanalytic and regulatory guidelines.
• Oversee and author methods, SOPs, protocols, technical reports, and relevant sections of documents for regulatory submissions as an SME.
• Work closely with Quality Assurance and Regulatory Affairs to ensure adherence to quality and regulatory guidelines.
• Author technical documents, protocols, and reports for assay development, validation, and clinical sample testing.
• Contribute to and ensure compliance and inspection readiness

• Act as a key technical liaison for Research Sciences, Research Operations, Clinical Development, Clinical Operations, Data Management, Biostatistics, and external vendors.
• Establish and maintain effective communication with CROs, internal and external collaborators.
• Flexibility and adaptability to additional projects and responsibilities as assigned to support the department's overall goals.

• An advance degree in relevant scientific discipline with 3-5 years experience in the biotech/pharmaceutical within a laboratory setting. PhD is strongly preferred.
• Extensive technical expertise with translational bioanalytical techniques, including gene expression (PCR, Nanostring, Spatial transcriptomics, NGS, bioinformatics), molecular and cellular biology, and protein quantitation (Western assays, MSD, ELISA).
• Demonstrated experience leading the implementation of bioanalytical studies under GCP/GLP compliance.
• Knowledge of neuromuscular biology, experience with gene and siRNA therapies in rare disease are strongly preferred.
• Experience with early and late-stage drug development and experimental design in a clinical research environment.
• Proven scientific leadership when working with collaborative, multi-functional teams.
• Excellent technical writing skills to support method validation reports, regulatory modules associated with NDA and BLA submission.
• A strong record of demonstrating analytical reasoning and creative problem-solving skills.
• Support communications and build relationships with key stakeholders, including internal and external collaborators, CROs and vendors
• Stretch activities and additional responsibilities as assigned in the fast-paced environment
• Experience with project and data management software (MS Project, WorkFront, PowerBI, etc.) is a plus.

#LI-Onsite #LI-TG1 This position requires work on site at one of Sarepta’s facilities in the United States. The targeted salary range for this position is $112,000 - $140,000 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.