Associate Director, Biomarker Science

Sarepta Therapeutics•Columbus, OH

10d•$152,800 - $191,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Previous experience in outward facing roles is a plus.

Responsibilities

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