Manager Translational Biology

The Opportunity to Make a Difference

Scientific Leadership:

• Using molecular biology and data analysis knowledge to develop and implement biomarker strategies in support of internal and health authorities decision making. Specifically drive identification of biomarkers technology and CRO selection and management methods development and validation in line with the context of use sample testing activities across multiple clinical and non clinical studies and analysis of biomarker data.
• Bench side and management of optimizations qualifications validations and sample testing with an emphasis on molecular methods e.g. PCR Western blot ELISA and highsensitivity ELISA based platforms.
• Flexibility and adaptability to additional projects and responsibilities as assigned to support the departments overall goals.

Operational Excellence:

• Manage projects and timelines organize/track complex information prioritize accordingly and have the ability to adjust to shifting priorities and demanding timelines when necessary quickly.
• Identify and implement processes improvements to foster crossfunctional collaboration enhance efficiency and compliance within Sarepta.
• Support crossfunctional data collection compilation for both nonclinical and clinical programs.

Team Management:

• Contribute to crossfunctional Biomarker team designed to refine and execute program PK PD and biomarker strategy supporting program development plan and regulatory strategy
• Identity build relationships and lead CRO teams dedicated to assay method development bioanalytical method validation and of nonclinical and clinical sample testing.
• Foster a collaborative and growthoriented internal team culture.

Clinical Integration:

• Collaborate closely with Bioanalytical leads Clinical Development and Clinical Operations to integrate data analytics into clinical protocols and reports seamlessly.
• Develop and execute data transfer in coordination with Clinical Operations Data Management Research Operations and CROs.

Regulatory Compliance and Quality Control:

• Ensure compliance with GDP GCP GLP bioanalytic and regulatory guidelines.
• Oversee and author methods SOPs protocols technical reports and relevant sections of documents for regulatory submissions as an SME.
• Work closely with Quality Assurance and Regulatory Affairs to ensure adherence to quality and regulatory guidelines.
• Author technical documents protocols and reports for assay development validation and clinical sample testing.
• Contribute to and ensure compliance and inspection readiness

Collaboration and Communication:

• Act as a key technical liaison for Research Sciences Research Operations Clinical Development Clinical Operations Data Management Biostatistics and external vendors.
• Establish and maintain effective communication with CROs internal and external collaborators.
• Flexibility and adaptability to additional projects and responsibilities as assigned to support the departments overall goals.

More about You

• An advance degree in relevant scientific discipline with 35 years experience in the biotech/pharmaceutical within a laboratory setting. PhD is strongly preferred.
• Extensive technical expertise with translational bioanalytical techniques including gene expression (PCR Nanostring Spatial transcriptomics NGS bioinformatics) molecular and cellular biology and protein quantitation (Western assays MSD ELISA).
• Demonstrated experience leading the implementation of bioanalytical studies under GCP/GLP compliance.
• Knowledge of neuromuscular biology experience with gene and siRNA therapies in rare disease are strongly preferred.
• Experience with early and latestage drug development and experimental design in a clinical research environment.
• Proven scientific leadership when working with collaborative multifunctional teams.
• Excellent technical writing skills to support method validation reports regulatory modules associated with NDA and BLA submission.
• A strong record of demonstrating analytical reasoning and creative problemsolving skills.
• Support communications and build relationships with key stakeholders including internal and external collaborators CROs and vendors
• Stretch activities and additional responsibilities as assigned in the fastpaced environment
• Experience with project and data management software (MS Project WorkFront PowerBI etc. is a plus.

What Now

Were always looking for solutionoriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.