Apply on Employer Site

SAGA Diagnostics · 1 day ago

Assoc. Director / Director, Clinical Development Operations

Morrisville, NC

Full-time

Onsite

Director/Executive

7+ years exp

SAGA Diagnostics is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). The Assoc. Director / Director, Clinical Development Operations will oversee the planning, execution, and monitoring of diagnostic aspects of clinical trials in oncology, managing cross-functional teams and vendor relationships to ensure high-quality trial conduct.

BiotechnologyGeneticsMedicalOncology

Responsibilities

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

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

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

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

Lead initiatives to improve SOPs, systems, and best practices in clinical operations

Identify and resolve operational inefficiencies with scalable, diagnostics-appropriate solutions

Oversee operational aspects of interventional and observational diagnostic clinical trials, including retrospective analyses

Prepare study protocols, informed consent forms, and training materials and SIV documents

Manage the Trial Master File (TMF) and ensure audit/inspection readiness

Oversee specimen logistics: site collection, shipping, accessioning, and processing coordination

Track study performance metrics and resolve issues with vendors or sites as they arise

Collaborate with internal stakeholders to align clinical operations with overall product strategy

Drive regulatory documentation and ensure compliance with IDE, CDx, IVDR, and other standards

Facilitate cross-functional internal and external (study PI’s and sites) meetings and vendor check-ins to ensure seamless trial execution

Provide leadership in team development, process optimization, and clinical operations scale-up

Qualification

Oncology clinical diagnosticsMolecular biologyRegulatory knowledgeProject management toolsBudget managementQuality assuranceProblem-solving skillsCommunication skills

Required

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