VP – Clinical Operations Excellence

The Opportunity:

We are building our Clinical Development Operations team, and we’re looking for you to help lay the foundation for our function.  As a Vice President, Clinical Operations Excellence you will lead an enablement function that ensures consistency of operations across all trials by establishing and implementing an infrastructure fostering efficiency, compliance and quality leading to a status of inspection-ready at all times. 

Your Role:

• Risk-Based Quality Management (RBQM) - Build, deploy and maintain all elements of a RBQM approach in accordance with ICH E6R2 requirements for all clinical trials.
• Vendor Performance Management
  • Define the “Relay Way” of executing clinical studies and implement a CRO-partnership model to support. Priorities include:
    • Define standard expectations and ways of working (i.e. Operations Manual)
    • In partnership with ClinOps Leads and CBO, lead the vendor JOCs
    • Define, implement and report measurable functional parameters framework metrics (OKMs/KPI/KRIs) for internal and external stakeholders with objective to drive development programs success (on time, on budget, and withing the scope) through data driven decision making.
  • Leads the Vendor Governance efforts
  • Partner with CBO and QA to ensure clear process for vendor qualification and maintenance of vendor qualification based on scope of services provided
  • Participate in preparation for vendor audits, review reports, ensure resolution of findings
• Clinical Documentation
  • Oversee eTMF team for all Relay TX Trials
• Quality, Training & Process Improvement and SOPs
• Quality
  • Vendor Quality Agreements (in alignment with QA)
  • Quality Events - Ensures Relay review and oversight of QE resolution with the vendor and drives the investigation, resolution and CAPAs on behalf of CDO for internal events
• Training & Process Improvements
  • Evaluate needs for CDO (and broader Precision Medicines) team training and either source training or develop in-house.
  • Lead lessons learned initiatives
  • Oversee training compliance across Precision Medicines
  • Drive the creation, evaluation and delivery of tools, templates, new systems, technologies, and guidance for best practice, reporting, and minimizing risk while ensuring quality is integrated into Relay’s processes in accordance with regulatory requirements (FDA, EMA, etc.) and ICH/GCP guidelines.
• SOPs
  • Oversee new SOP (WI, Form, Template) creation for CDO-owned SOPs
  • Oversee the periodic review of CDO-owned QDs and cross-functional SOPs
  • Drive CDO review of cross-functional SOPs

Your Background:

• You bring 10+ years of experience in the biopharma or CRO industry with a thorough understanding of clinical study processes
• You are a proactive problem solver who identifies solutions to problems before they arise
• You are recognized as a clinical operations expert, with a prior track record of success and history of innovative program and study execution that use the latest technologies to facilitate study execution, accelerate timelines, maintain data integrity, and satisfy regulatory authority requirements
• You have a strong and current knowledge in Good Clinical Practices and ICH Guidelines and the application to the conduct of clinical studies
• You bring successful experience from at least one fast-paced entrepreneurial biotech company
• You display strategic planning, attention to detail, and an analytical approach to problem solving
• You are a leader who communicates and demonstrates vision and commitment
• You eagerly mentor and develop talent in the organization

#JO1