Assoc. Director Director, Clinical Development Operations
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Job Location:
Morrisville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
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
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 SAPs 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
Tasks and Key Deliverables:
- 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 PIs and sites) meetings and vendor check-ins to ensure seamless trial execution.
- Provide leadership in team development process optimization and clinical operations scale-up.
Requirements
- Scientific Bachelors a minimum; Masters (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.
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.
SAGA Diagnostics is an equal opportunity employer fully committed to achieving a diverse and inclusive workplace that embraces and encourages applicants of every background. The companys policy regarding equal employment opportunity means that all decisions regarding recruitment hiring benefits wage and salary administration scheduling disciplinary action and termination will be made without unlawful discrimination on the basis of sex gender race color age national origin religion disability medical condition genetic information marital status sexual orientation gender identity or expression citizenship status pregnancy or maternity veteran status or any other status protected by applicable federal state or local law. If you require reasonable accommodation in completing an application interviewing or otherwise participating in the employee selection process please direct your inquiries to SAGA Diagnostics is a participant in the E-Verify program learn more about the program and review our required disclosureshereandhere.
Required Experience:
Director
Key Skills
- Employee Relations
- Employee Evaluation
- Management Experience
- Profit & Loss
- Conflict Management
- Operations Management
- Project Management
- Budgeting
- Leadership Experience
- Supervising Experience
- Leadership management
- Financial Planning
About Company
SAGA Diagnostics is a personalized cancer medicine and disease monitoring company focused on molecular genetic analyses of circulating tumor DNA and tissue biopsies.
