Manager, Biological Sciences

Insulet Corporation

. Oversee outsourced pre-clinical animal studies supporting medical device development .

Posted 11/9/2026full-timeActon • Massachusetts • United StatesMid-LevelSenior💰 $130,400 - $195,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in overseeing pre-clinical animal studies, ensuring regulatory compliance, and managing budgets and timelines. Proficient in biostatistics, experimental design, and effective communication across diverse teams.

Highest-signal resume keywords

Pre-Clinical Research ManagementBiostatistics ExpertiseProject Management SkillsRegulatory Compliance KnowledgeVendor Relationship Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Biostatistical Data EvaluationExperimental DesignStudy Protocol DevelopmentSample Size CalculationStatistical Power AnalysisBudget ManagementResource Allocation OptimizationCRO CoordinationGLP ComplianceFDA Regulations

Soft Skills

Strong Communication SkillsCollaboration AbilitiesLeadership in Review MeetingsNegotiation SkillsAbility to Manage Multiple Priorities

Certifications & Qualifications

AALAS CertificationMaster's Degree in Scientific FieldPhD in Relevant Scientific DisciplineDVM/VMD

Industry Keywords

Medical Device DevelopmentAnimal Welfare RegulationsContract Research OrganizationsQuality AssuranceSOP Compliance

About the role

Key responsibilities & impact

Oversee outsourced pre-clinical animal studies supporting medical device development
Ensure scientific integrity, regulatory compliance, and efficient resource management
Serve as primary liaison between internal teams and external contract research organizations (CROs)
Coordinate pre-clinical study initiation and final authorization processes
Coordinate study execution with CROs
Evaluate biostatistical data
Manage budgets and timelines to deliver results informing product safety and efficacy
Develop and manage pre-clinical study plans with R&D, Regulatory, and Quality teams
Ensure CRO adherence to protocols, timelines, and GLP/non-GLP requirements
Coordinate protocol approvals, material shipments, and data transfer for outsourced animal studies
Review and approve study protocols and endpoints
Evaluate biostatistical methods and results
Provide input on study design, sample size calculations, and statistical power analysis
Develop and manage vendor contracts, budgets, and cost tracking
Optimize resource allocation and negotiate cost-effective CRO solutions
Ensure compliance with FDA, ISO 10993, and applicable animal welfare regulations
Maintain documentation for audits and regulatory submissions
Collaborate with 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 stakeholders
Lead internal review meetings and provide actionable recommendations

Requirements

What you’ll need

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

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
Additional employee wellness programs
Incentive compensation eligibility