Associate Director, Biomarker Science

About Sarepta

Sarepta is at the forefront of genetic medicine, holding a leadership position in Duchenne muscular dystrophy (Duchenne) and building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, Sarepta launched its fourth therapy and the first-ever gene therapy to treat Duchenne. We seek individuals who see unlimited potential in themselves and are motivated by an unwavering commitment to patients.

What Sarepta Offers

• Physical and Emotional Wellness: Comprehensive support for well-being.
• Financial Wellness: Resources to help manage financial health.
• Support for Caregivers: Programs to assist employees with caregiving responsibilities.

For a full list of benefits, visit Sarepta’s careers page.

About the Role

The Associate Director of Biomarker Sciences assists in overseeing clinical and non-clinical biomarker development across Sarepta’s pipeline. This role requires expertise in biomarker discovery, development, and implementation, with an emphasis on Sarepta’s siRNA pipeline. The position involves collaboration with internal teams, external partners, and regulatory agencies to support program needs and deliver critical milestones.

Responsibilities

• Assist in developing and implementing biomarker strategies aligned with program development plans (nonclinical, translational, and clinical) and regulatory strategies, with a focus on early and translational programs.
• Collaborate with functional leads (nonclinical, research operations, molecular biology) to support data generation efforts for program biomarker strategies.
• Conduct literature reviews to identify novel PK or 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 (CROs) responsible for executing non-clinical and clinical data generation, including assay development and validation.
• Represent Translational Biology on internal functional sub-teams (clinical, non-clinical) and work cross-functionally to drive program milestones and long-term planning.
• Aid in generating key materials for data disclosures (internal and external) and participate in presentations related to biomarker datasets and their interpretation.
• Participate in regulatory writing for translational and biomarker documents (e.g., INDs, CTAs, NDAs) and assist with regulatory agency requests.

Requirements

• PhD in Pharmacology, Biochemistry, Bioinformatics, or a related field with 4+ years of relevant experience in the biopharmaceutical industry, focusing on translational research.
• Expertise in neurobiology/neuromuscular biology, siRNA therapeutics, and drug development in rare diseases.
• Experience developing bioassays, particularly protein-binding assay platforms.
• Experience with big datasets and/or expertise in “-omics” platforms (RNASeq, Single cell, proteomics).
• Expertise in authoring and critically reviewing technical, clinical, and regulatory documents.
• Experience with qualification and validation of bioanalytical assays and biomarkers under FDA, EMA, ICH GCP/GLP, and other applicable guidelines.
• Experience in vendor management, including quality, capability, data flow, interpretation, and reporting.
• Demonstrated ability to work cross-functionally in a diverse, matrixed environment.
• Ability to manage multiple complex projects simultaneously.
• Exceptional verbal and written communication skills; outward-facing experience is a plus.

Schedule

This position is hybrid, requiring on-site work at one of Sarepta’s U.S. facilities and attendance at Company-sponsored in-person events as needed.

Pay

The targeted salary range for this position is $152,800 - $191,000 per year. The offer is commensurate with education, training, experience, external market conditions, role criticality, and internal equity.

Candidates must be authorized to work in the U.S. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.