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 compliance with FDA, ISO 10993, and applicable animal welfare regulations.
• Maintain documentation for audits and regulatory submissions, including study reports and statistical analyses.
• Collaborate with internal Quality Assurance to monitor CRO compliance with SOPs and GLP standards.

Cross-functional Leadership

• Partner with engineering, clinical, and regulatory teams to align pre-clinical strategy with overall product development.
• Communicate study progress, risks, and outcomes to senior leadership and project stakeholders.
• Lead internal review meetings and provide actionable recommendations based on study data.

Basic Qualifications :

• At least master’s degree in scientific, biomedical, or engineering field.
• At least 3 years in preclinical research or laboratory animal management, preferably in medical devices.
• Ability to lead internal review meetings and provide actionable recommendations based on study data.
• Strong background in biostatistics, experimental design, and interpretation of pre-clinical data.
• Ability to manage multiple priorities in a fast paced‑innovation environment.
• Strong communication and collaboration skills with the ability to work effectively across diverse teams.
• Strong project management and budgeting skills as well as negotiation abilities.

Preferred Qualification:

• PhD in relevant scientific discipline or DVM/VMD.
• AALAS Certification
• At least 5 years in preclinical research or laboratory animal management, preferably in medical devices.
• Experience managing outsourced studies and vendor relationships.

Travel Requirements

• Up to 10% domestic travel for vendor audits, study oversight, and meetings.
• Up to 50% on-site presence at local animal laboratory for study coordination and monitoring.

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $130,400.00 - $195,650.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.