Associate Director, Biomarker Science

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

Why Sarepta? Why Now?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• Financial Wellness

• Support for Caregivers
  

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

The Associate Director of Biomarker Sciences assists in the oversight of clinical and non-clinical biomarker development across Sarepta's pipeline. This role requires expertise in biomarker discovery, development, and implementation in clinical and non-clinical stage programs with emphasis on Sarepta's siRNA pipeline. This role requires effective communication and collaboration, working with scientists and leaders across the company, partnering with external organizations and regulatory agencies. Working in a global matrix environment to support program needs and deliver on critical milestones, this role requires strong communication of scientific concepts including the relevance and design of various bio-assays and the data generated from them. The candidate will also support the preparation of regulatory submissions and data disseminations as needed. This role will also work cross-functionally to drive data analysis efforts and lead efforts to extract critical information from existing datasets.

The Opportunity to Make a Difference

Primary Responsibilities Include:

• Assist the development and implementation of biomarker strategies consistent with the program development plans (nonclinical, translational and clinical) and regulatory strategies with emphasis on early and translational programs
• Collaborate with other functional leads (nonclinical, research operations, molecular biology) to support data generation efforts which support program biomarker strategies
• Conduct literature reviews to identify novel PK or PD biomarkers to support program needs and develop plan for implementation in non-clinical and clinical studies
• Perform extensive data analysis efforts to interpret non-clinical and clinical PD data and guide decision-making efforts
• Oversee Contract Research Organizations responsible for executing non-clinical and clinical data generation efforts including assay development and validation
• Represent Translational Biology on various internal functional sub-teams (clinical, non-clinical) and work cross-functionally to drive program milestones and participate in long-term planning efforts
• Aid in the generation of key materials for data disclosures (both internal and external) and participate in presentation efforts related to biomarker datasets and their interpretation
• Participate in regulatory writing efforts for translational and biomarker documents such as INDs, CTAs, and NDAs as well as assist with the completion of Requests for Information from regulatory agencies

More about You

Desired Education and Skills:

• PhD in Pharmacology, Biochemistry, Bioinformatics or 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 the rare disease spaces
• Experience in development of bioassays, e.g., biomarkers with emphasis on 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 from quality, capability, data flow, interpretation, and reporting
• Demonstrated ability to work cross-functionally in a diverse matrixed environment
• Demonstrated ability to manage multiple complex projects simultaneously
• Exceptional verbal and written communication skills. Previous experience in outward facing roles is a plus.

What Now?

We're always looking for solution-oriented, critical thinkers.

#LI-HybridThis position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $152,800 - $191,000 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.