Manager, Biological Sciences
Insulet Corporation
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).
Job description
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.
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.
Requirements
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
- Employee Wellness Programs
- Incentive Compensation
Company overview
Insulet Corporation (NASDAQ: PODD) is an innovative medical device company headquartered in Acton, Massachusetts, founded in 2000 with a mission to improve the lives of people with diabetes. The company specializes in developing, manufacturing, and marketing the revolutionary Omnipod Insulin Management System, which provides a unique alternative to traditional insulin delivery methods. The Omnipod system features a tubeless, disposable wearable Pod that delivers up to three days of continuous insulin without the need for needles or tubing. Insulet's flagship product, the Omnipod 5 Automated Insulin Delivery System, integrates with continuous glucose monitors to manage blood sugar levels automatically, eliminating multiple daily injections and fingersticks. With operations spanning 25 countries across North America, Europe, the Middle East, and Asia Pacific, Insulet has established itself as a global leader in diabetes management technology. The company employs between 1,001-5,000 professionals dedicated to advancing diabetes care through innovative medical device solutions.