Assoc. Director​/Director, Clinical Development Operations

SAGA Diagnostics is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). The company’s mission is to improve precision cancer medicine, provide more accurate treatment monitoring, and improve patient survival using minimally-invasive liquid biopsy cancer testing services. SAGA’s proprietary tests can help patients, oncologists, and drug developers detect actionable mutations, stratify patient groups, and monitor treatment response, residual disease, and disease recurrence at unprecedented sensitivity and scale.

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.

• 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.

• 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.

• 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…