Genepool Networks · 1 week ago
Associate Director / Director Clinical Operations
Genepool Networks is a company focused on innovative clinical solutions, and they are seeking an Associate Director / Director of Clinical Operations. The role involves leading the clinical operations plan for therapeutic programs, managing risks, and ensuring compliance with regulatory standards while collaborating with cross-functional teams.
Responsibilities
Lead the clinical operations plan for a therapeutic program across all studies
Translate clinical development strategy into executable operational plans, timelines, and resourcing
Manage program-level risks, dependencies, and critical path; escalate issues proactively
Maintain visibility into CRO, vendor, and site performance metrics
Review and approve study-level plans and deliverables to ensure consistency across the program
Hold CROs and vendors accountable for quality, performance, and budget adherence
Partner with Clinical Development, Regulatory, CMC, Data Management, Biostatistics, Safety, and Quality
Represent Clinical Operations in planning and governance discussions
Support operational readiness for regulatory milestones and inspections
Lead operational status reporting, including timelines, risks, and trade-offs
Ensure inspection-ready TMF and compliance with ICH-GCP, SOPs, and regulatory standards
Support audits, inspections, and continuous improvement initiatives
Contribute to Clinical Operations SOPs, tools, and best practices
Qualification
Required
Bachelor's degree (Life Sciences or related field preferred)
Minimum of 8 years of clinical operations experience, including hands-on trial management
Minimum of 3 years in a small biotech
Deep understanding of clinical research processes, GCP guidelines, and regulatory requirements
Excellent communication and interpersonal skills with the proven ability to manage external relationships
Close attention to detail and commitment to quality