Senior Research Associate, Translational Biology
Company: Sarepta Therapeutics
Posted on: November 22, 2021
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
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
- 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
- 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
- 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
- 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
- Facility dependent requirement to support laboratory
experiments and scientific needs.
Desired 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,
- 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
- Support communications and build relationships with key
stakeholders including CROs, vendors and external
- A strong record of demonstrating critical thinking and creative
- 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
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action
employer and participates in e-Verify.
Keywords: Sarepta Therapeutics, Columbus , Senior Research Associate, Translational Biology, Other , Columbus, Ohio
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