Manager, Biological Sciences

Insulet Corporation•Acton, MA

1d•$130,400 - $195,650

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, and serves 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 develops and manages study plans with R&D, Regulatory, and Quality teams; oversees CRO adherence to protocols, timelines, and GLP/non-GLP requirements; and coordinates study logistics, including protocol approvals, material shipments, and data transfer. It reviews protocols and endpoints, evaluates statistical methods and results, and advises on study design, sample sizes, and statistical power. The manager manages study budgets, vendor contracts, and costs; optimizes resources across studies; and negotiates cost-effective CRO arrangements without compromising quality. The role also ensures compliance with FDA, ISO 10993, and applicable animal welfare regulations, maintains audit and submission documentation, and collaborates with Quality Assurance on CRO compliance with SOPs and GLP standards. Working across engineering, clinical, and regulatory teams, the manager aligns pre-clinical strategy with product development, communicates study progress, risks, and outcomes to leadership and stakeholders, and leads internal review meetings with actionable recommendations. The role requires up to 10% domestic travel and up to 50% on-site presence at a local animal laboratory.

Requirements

At least a master's degree in a scientific, biomedical, or engineering field.
At least 3 years 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 manage multiple priorities in a fast-paced innovation environment.
Strong communication and collaboration skills and ability to work effectively across diverse teams.
Strong project management and budgeting skills, as well as negotiation abilities.
Ability to lead internal review meetings and provide actionable recommendations based on study data.

Nice To Haves

PhD in a 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.

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 for robust 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 for 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.