Manager, Biological Sciences

Insulet Corporation•Acton, MA

11h

About The Position

The Pre-Clinical Medical Device Manager oversees outsourced pre-clinical animal studies supporting medical device development. The 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 coordinates study initiation, final authorization, and execution; evaluates biostatistical data; and manages budgets and timelines to deliver results that inform product safety and efficacy. The position works with R&D, Regulatory, Quality, engineering, and clinical teams to plan and oversee studies, review study protocols and endpoints, assess statistical methods and findings, and coordinate study logistics. It also manages CRO contracts, costs, resources, and timelines, and supports compliance with FDA, ISO 10993, GLP/non-GLP requirements, and applicable animal welfare regulations. The manager maintains documentation for audits and regulatory submissions, communicates study progress and risks to stakeholders and senior leadership, and leads internal review meetings. The role involves up to 10% domestic travel for vendor audits, study oversight, and meetings, and up to 50% on-site presence at a local animal laboratory for study coordination and monitoring. The stated U.S. annual base salary range is $130,400 to $195,650; the position may also be eligible for incentive compensation.

Requirements

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

Nice To Haves

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

Responsibilities

Develop and manage pre-clinical study plans in collaboration with R&D, Regulatory, and Quality teams.
Serve as the primary point of contact for CROs and ensure adherence to protocols, timelines, and GLP/non-GLP requirements.
Coordinate outsourced animal-study logistics, including protocol approvals, material shipments, and data transfer.
Review and approve study protocols and endpoints for relevance to device performance and safety.
Evaluate biostatistical methods and results to support robust data interpretation and regulatory compliance.
Provide input on study design, sample size calculations, and statistical power analysis.
Develop and manage budgets for outsourced animal studies, including vendor contracts and cost tracking.
Optimize resource allocation across studies to meet timelines and financial targets.
Negotiate with CROs to secure cost-effective solutions without compromising quality.
Ensure 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.
Partner with engineering, clinical, and regulatory teams to align pre-clinical strategy with 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.
Coordinate and monitor studies at a local animal laboratory and travel for vendor audits, study oversight, and meetings as needed.