Manager, Biological Sciences

Job Summary

The Pre-Clinical Medical Device Manager will oversee outsourced pre-clinical animal studies supporting medical device development. This role ensures scientific integrity, regulatory compliance, and efficient resource management while serving as the primary liaison between internal teams and external contract research organizations (CROs). The manager will coordinate pre-clinical study initiation and final authorization process, coordinate study execution with CRO, evaluate biostatistical data, and manage budgets and timelines to deliver high-quality results that inform product safety and efficacy.



Pre-clinical study coordination and oversight:

• Develop and manage pre-clinical study plans in collaboration with R&D, Regulatory, and Quality teams.
• Serve as primary point of contact for CROs, ensuring adherence to protocols, timelines, and Good Laboratory Practices (GLP)/non-GLP requirements.
• Coordinate logistics for outsourced animal studies, including protocol approvals, material shipments, and data transfer.

Scientific review & biostatistics:

• Review and approve study protocols and endpoints for relevance to device performance and safety.
• Evaluate biostatistical methods and results to ensure robust data interpretation and regulatory compliance.
• Provide input on study design, sample size calculations, and statistical power analysis.

Budget and resource management

• Develop and manage budgets for outsourced animal studies, including vendor contracts and cost tracking.
• Optimize resource allocation across multiple studies to meet timelines and financial targets.
• Negotiate with CROs to ensure cost-effective solutions without compromising quality.
• Ensure regulatory ...

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