Associate Director, Biomarker Science - Translational Leader

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 153,000 - 191,000; Full time

Job summary

Sarepta Therapeutics is seeking an Associate Director of Biomarker Sciences to lead biomarker discovery, development and implementation across clinical and non-clinical programs, with emphasis on the siRNA platform. You will drive cross-functional collaboration, guide regulatory submissions, and oversee biomarker data generation in a global matrix environment.

The role requires a PhD with 4+ years in translational research, expertise in neurobiology, and experience with assay development, -omics

Qualifications

• PhD in Pharmacology, Biochemistry, Bioinformatics or related field with 4+ years of translational research experience.
• Expertise in neurobiology/neuromuscular biology, siRNA therapeutics, and drug development in rare diseases.
• Experience in developing bioassays and biomarkers with protein-binding assay platforms.
• Experience with big datasets and -omics (RNASeq, single cell, proteomics).
• Experience drafting technical, clinical and regulatory documents.
• Experience with qualification and validation of bioanalytical assays and biomarkers under FDA/EMA/ICH guidelines.
• Experience in vendor management and data interpretation.
• Ability to work cross-functionally in a matrix environment.
• Strong written and verbal communication; outward-facing experience is a plus.

Responsibilities

• Assist development and implementation of biomarker strategies aligned with program development and regulatory plans.
• Collaborate with nonclinical, research operations, and molecular biology to support data generation for biomarker strategies.
• Conduct literature reviews to identify PK/PD biomarkers and plan implementation in studies.
• Perform extensive data analysis to interpret PD data and support decision making.
• Oversee CROs for nonclinical and clinical data generation including assay development and validation.
• Represent Translational Biology on internal sub-teams and drive milestone planning.
• Generate materials for data disclosures and contribute to presentations of biomarker data.
• Support regulatory writing for translational and biomarker documents such as INDs/CTAs/NDAs.

Skills

Neurobiology expertise

siRNA therapeutics

Bioinformatics

Biomarker development

Data analysis

Regulatory writing

Cross-functional collaboration

Communication skills

Project management

Vendor management

Education

PhD in Pharmacology, Biochemistry, Bioinformatics or related field with 4+ years in biopharma translational research

Job description

Sarepta Therapeutics is seeking an Associate Director of Biomarker Sciences to lead biomarker discovery, development and implementation across clinical and non-clinical programs, with emphasis on the siRNA platform. You will drive cross-functional collaboration, guide regulatory submissions, and oversee biomarker data generation in a global matrix environment.

The role requires a PhD with 4+ years in translational research, expertise in neurobiology, and experience with assay development, -omics