Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit www.sarepta.com
Sarepta Therapeutics is seeking a motivated individual with experience in the field of clinical operations, Data processing/analytics, vendor management and data analysis to translational clinical assay activities. This person will contribute to assay development, validation and clinical sample testing activities to evaluate treatment efficacy in ongoing clinical and non-clinical Sarepta trials. Additional duties include contributing to laboratory compliance and inspection readiness activities and drafting methods, SOPs, protocols and technical reports.
The candidate will be responsible for sample logistics and data management across multiple clinical and non-clinical trials for multiple sample types. They would also assist in early and late-stage optimizations, qualifications and validations using molecular biology and histology techniques with a special interest in morphometric technologies. They will be responsible for managing projects, timelines, SOW’s and PO’s with external contract research organizations (CROs) and vendors to support analysis of patient samples from ongoing Sarepta clinical trials. This position will be a key technical point of contact for Clinical Operations, Data Management, Biostatistics, vendors for data transfer and analysis needs. The position is facility dependent and will be located at the Sarepta Therapeutics site in Columbus, Ohio.
Primary responsibilities include but are not limited to:
- Coordinate closely with Clinical Operations and the Biomarkers team to support the implementation of sample testing in the clinical protocols.
- Develop data transfer and analysis plans in collaboration with Clinical Operations, Data Management, Biostatistics, Medical Directors and Clinical leads and associated vendors.
- Manage SOW’s, Contracts and PO’s related to clinical trials.
- Conducts supportive activities at the Sarepta laboratories, interacts with GEIC research, RNA pre-clinical team, Biomarkers team, Bioanalytics and QA groups.
- Assist in Morphometric image analysis and data collection compilation for non-clinical and clinical programs.
- Assists in the Development, design, and implement of new image analysis algorithms
- Early development and optimization of new and/or improved assays for additional clinical biomarker capabilities.
- Assists in collection and compiling raw data in accordance with appropriate statistical procedures, inclusive of graphs, tables, and photographs of the results for regulatory review.
- Assist in authoring relevant sections of clinical documents pertaining to biological sample testing (e.g. Clinical Protocols, Informed Consent, Clinical Study Reports, Investigator Brochures) and documentation for submission to regulatory agencies.
- Author relevant sections of internal reports pertaining to operations, sample management, data transfer and analysis.
- Work closely with Quality Assurance and Regulatory Affairs to ensure compliance with appropriate regulatory guidelines.
- Manage communications and build relationships CROs and external collaborators.
· Maintain compliant laboratory records. Author technical documents, protocols and reports connected to assay development, validation and clinical sample testing.
· Assist laboratory staff in maintaining laboratory compliance and inspection readiness.
· This position will cover both non-clinical and clinical interactions with internal and external collaborations
· Assists in training new employees on assigned responsibilities outlined above.
- Facility dependent requirement to support laboratory experiments and scientific needs.
Education and Skills Requirements:
- BS degree in scientific disciple/MS degree preferred with 5+ years of laboratory experience in the healthcare, biotech/pharmaceutical industry or equivalent.
- Demonstrated experience managing implementation of bioanalytical studies under GCP/GLP compliance.
- Direct experience coordinating research trial activities for early and late-stage drug development, clinical operations, and experimental design in a clinical research environment.
- Proven scientific leadership when working with collaborative, multi-functional teams.
- Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
· A strong record of demonstrating analytical reasoning and creative problem-solving skills.
- Demonstrated experience authoring submissions documents to regulatory agencies.
· Support communications and build relationships with key stakeholders including CROs, vendors and external collaborators
· A strong record of demonstrating critical thinking and creative problem-solving skills.
- Experience with project management software (MS Project, Spotfire, Smartsheets, JIRA, etc.) is a plus.
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