Associate Director, Biomarker Science
Sarepta Therapeutics
August 23, 2026
Remote friendly (United States)
United States
Clinical Research and Development
The Associate Director of Biomarker Sciences assists in the oversight of clinical and non-clinical biomarker development across Sarepta’s pipeline, with emphasis on siRNA pipeline programs.
Primary Responsibilities Include
- Assist in developing and implementing biomarker strategies aligned with program development and regulatory plans (nonclinical, translational, clinical), especially early/translational programs
- Collaborate with nonclinical, research operations, and molecular biology leads to support biomarker data generation
- Conduct literature reviews to identify novel PK/PD biomarkers and develop implementation plans for non-clinical and clinical studies
- Perform extensive data analysis to interpret non-clinical and clinical PD data and guide decision-making
- Oversee Contract Research Organizations for non-clinical/clinical data generation, including assay development and validation
- Represent Translational Biology on internal clinical/non-clinical sub-teams to drive milestones and long-term planning
- Support internal/external data disclosure materials and biomarker dataset presentation efforts
- Participate in regulatory writing for translational/biomarker documents (INDs, CTAs, NDAs) and Requests for Information
Desired Education and Skills
- PhD in Pharmacology, Biochemistry, Bioinformatics or related field + 4+ years biopharma translational research experience
- Expertise in neurobiology/neuromuscular biology, siRNA therapeutics, and rare disease drug development
- Bioassay development (protein-binding assay platforms)
- Experience with big datasets and/or -omics (RNASeq, single cell, proteomics)
- Authoring/reviewing technical, clinical, and regulatory documents
- Qualification/validation of bioanalytical assays/biomarkers under FDA, EMA, ICH GCP/GLP and related guidelines
- Vendor management
- Cross-functional/matrix project management; exceptional verbal and written communication
Application Instructions
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and value kindness and integrity.
Hybrid: expected to work on-site in the U.S. and/or attend in-person events.
Primary Responsibilities Include
- Assist in developing and implementing biomarker strategies aligned with program development and regulatory plans (nonclinical, translational, clinical), especially early/translational programs
- Collaborate with nonclinical, research operations, and molecular biology leads to support biomarker data generation
- Conduct literature reviews to identify novel PK/PD biomarkers and develop implementation plans for non-clinical and clinical studies
- Perform extensive data analysis to interpret non-clinical and clinical PD data and guide decision-making
- Oversee Contract Research Organizations for non-clinical/clinical data generation, including assay development and validation
- Represent Translational Biology on internal clinical/non-clinical sub-teams to drive milestones and long-term planning
- Support internal/external data disclosure materials and biomarker dataset presentation efforts
- Participate in regulatory writing for translational/biomarker documents (INDs, CTAs, NDAs) and Requests for Information
Desired Education and Skills
- PhD in Pharmacology, Biochemistry, Bioinformatics or related field + 4+ years biopharma translational research experience
- Expertise in neurobiology/neuromuscular biology, siRNA therapeutics, and rare disease drug development
- Bioassay development (protein-binding assay platforms)
- Experience with big datasets and/or -omics (RNASeq, single cell, proteomics)
- Authoring/reviewing technical, clinical, and regulatory documents
- Qualification/validation of bioanalytical assays/biomarkers under FDA, EMA, ICH GCP/GLP and related guidelines
- Vendor management
- Cross-functional/matrix project management; exceptional verbal and written communication
Application Instructions
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and value kindness and integrity.
Hybrid: expected to work on-site in the U.S. and/or attend in-person events.