Biomarker Science Leader, Translational Research

Sarepta Therapeutics; North Carolina; Hybrid; USD 153,000 - 191,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics is seeking an Associate Director of Biomarker Sciences to oversee biomarker discovery, development and implementation across the pipeline, with emphasis on siRNA programs. You will collaborate with scientists and external partners, drive data analysis, and support regulatory submissions in a global matrix environment.

The role requires strong communication, cross-functional leadership, and a track record in translational biology within the biopharmaceutical industry.

Qualifications

• PhD required with 4+ years in biopharma translational research.
• Expertise in neurobiology/neuromuscular biology and siRNA therapeutics.
• Experience with bioassays and omics platforms.
• Strong regulatory documentation experience (INDs, CTAs, NDAs).
• Vendor management and cross-functional collaboration across a global matrix.

Responsibilities

• Assist development and implementation of biomarker strategies aligned with program plans and regulatory strategies.
• Collaborate with functional leads to support biomarker data generation.
• Review literature to identify novel PK/PD biomarkers for nonclinical and clinical studies.
• Analyze nonclinical and clinical PD data to inform decision-making.
• Oversee CROs for data generation, assay development and validation.
• Represent Translational Biology on internal sub-teams and drive milestones.
• Contribute to data disclosures and presentations of biomarker datasets.
• Assist regulatory writing for translational and biomarker documents.

Skills

Neurobiology

siRNA therapeutics

Biomarker discovery

Omics platforms

Regulatory writing

Education

PhD in Pharmacology, Biochemistry, Bioinformatics or related field

Job description

Sarepta Therapeutics is seeking an Associate Director of Biomarker Sciences to oversee biomarker discovery, development and implementation across the pipeline, with emphasis on siRNA programs. You will collaborate with scientists and external partners, drive data analysis, and support regulatory submissions in a global matrix environment.

The role requires strong communication, cross-functional leadership, and a track record in translational biology within the biopharmaceutical industry.