Manager, Biological Sciences
Core
Oversee outsourced pre-clinical animal studies to ensure scientific integrity, regulatory compliance, and efficient resource management for medical device development.
Role type
Manager, Pre-Clinical Medical Device Studies
Builds
Pre-clinical study plans, protocols, and data supporting product safety and efficacy
Domain
Medical Devices / Pre-Clinical Research
Required skills
Pre-clinical research management, Biostatistics, Experimental design, Budget management, Vendor/CRO negotiation, Regulatory compliance (FDA/ISO/GLP), Project management
Preferred skills
PhD in scientific discipline, DVM/VMD, AALAS Certification, Managing outsourced studies
Technologies
GLP, ISO 10993, FDA regulations, Biostatistical software
Responsibilities
Develop and manage pre-clinical study plans with R&D and Regulatory teams; Coordinate logistics for outsourced animal studies; Review and approve study protocols and endpoints; Evaluate biostatistical methods and results; Manage budgets and negotiate with CROs; Maintain documentation for audits and regulatory submissions.
Seniority
Manager, hands-on leadership