Assoc. Director / Director, Clinical Development Operations

SAGA Diagnostics • Morrisville, NC

9d

About The Position

The Assoc. Director / Director, Clinical Development Operations will have a strong blend of scientific knowledge, clinical operations and regulatory expertise, and proven leadership ability to oversee the planning, execution, and monitoring of diagnostic aspects of clinical trials in oncology. Ability to manage cross-functional teams, handle vendor relationships, and ensure all trials are conducted efficiently, within budget, and to the highest quality standards. Willingness to work as a hand-on and tactical team member in a start-up environment

Requirements

• Scientific Bachelor's a minimum; Master's (MBA/MS) preferred and PhD a plus
• 7+ years in oncology clinical diagnostics/therapeutic trials, with significant time in molecular pathology/genomics in a biotech/pharma/CRO environment.
• Proven experience in leading teams and managing complex operations. Willingness to perform tactical aspects of clinical operations
• Familiar with all aspects of clinical trial diagnostics operations
• Strong understanding of molecular biology, diagnostics, NGS and oncology. · Regulatory knowledge (CAP, CLIA, IVDR)
• Problem-solving and communication skills, competency in project management tools and MS applications
• Quality assurance, budget management, and performance improvement.

Responsibilities

• Clinical Study Strategy & Oversight
• Partner with the clinical team to design and execute diagnostic clinical studies supporting product development and regulatory submissions.
• Develop and manage study plans, budgets, timelines, and resource allocation.
• Operational Execution
• Oversee day-to-day operations of clinical trials, ensuring adherence to protocols, GCP, and timelines.
• Manage clinical specimen shipping and logistics, sample trackers, and coordination with internal laboratory teams.
• Ensure that documentation and trial activities are audit ready.
• Cross-Functional & Vendor Leadership
• Collaborate cross-functionally with Regulatory, Quality, Medical Affairs, R&D, Lab Ops, Commercial, etc.
• Manage CROs, central labs, and clinical sites, including vendor selection, contract negotiation, and performance oversight.
• Act as the primary operational point of contact for investigators and external collaborators.
• Documentation & Compliance
• Contribute to and review key clinical documents (protocols, SAP’s, ICFs, CRFs, monitoring plans).
• Ensure full regulatory compliance with FDA, ICH-GCP, CLIA, IVDR, and other applicable standards.
• Support audit preparation and response in collaboration with Quality and Regulatory teams.
• Process Development & Continuous Improvement
• Lead initiatives to improve SOPs, systems, and best practices in clinical operations.
• Identify and resolve operational inefficiencies with scalable, diagnostics-appropriate solutions

Benefits

• Competitive Compensation and company wide benefits plan
• Opportunities for career advancement and professional development.
• A collaborative and innovative work environment dedicated to improving oncology outcomes.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees