Vice President, Business Enablement - Clinical Operations

Summary 

The Vice President, Business Enablement, Clinical Operations is responsible for leading and managing the Business Enablement Department within Clinical Operations.  This includes, but is not limited to, project management of critical business operations, including systems associated with clinical trial planning and conduct, evaluation, and recommendation of work to be performed internally and outsourced to strategic partners, creation of standard processes to drive efficiency across clinical teams, sponsor oversight and inspection readiness and operational management of biological samples within Arcus’ remit and financial stewardship of the business and portfolio.  This role oversees subfunctions that include, but may not be limited to, Records Management, Monitoring Oversight, BioSample Operations, Inspection Readiness, Systems and Central Services, and Process Improvement/Training.  This role will work cross-functionally with legal, quality, finance, commercial, clinical supply, program management, alliance management, compliance, IT, in addition to all departments within the clinical development organization.  This position reports to the Sr. Vice President of Clinical Operations. 

Responsibilities

• Develop and execute strategic planning for Clinical Operations Business Operations, including but not limited to clinical systems, biosample management, oversight and monitoring activities, operational inspection readiness, policies and financial stewardship.
• In collaboration with Sr. Vice President and other Functional Leads, identify opportunities to streamline the delivery of clinical trials and optimize company-wide cross-functional synergies and improvements.
• Lead the strategic plan and utilization of operational clinical trial systems, assessment of technology gaps and best value for scalable fit to the Arcus portfolio, aligning with resource management and vendor capabilities, value and outputs.
• Accountable to the GCP compliance of operational clinical trial systems and their inputs and outputs.
• Maintain a resource management plan, training and development assessments and ensure staff is compliant and clinical trials are resourced appropriately for functions within the remit of role.
• Develop and maintain standard operating procedures (SOP), processes, standards, and inspection readiness activities related to the Clinical Operations Organization.
• Lead Sponsor Oversight activities through guidance on the creation, implementation, and close out of Vendor Oversight Plans and clinical site oversight visits, including the conduct of gap analysis. Ensure oversight is compliant and timely through the development of processes, resource assignments and use of technology.
• Oversee the Biosample Operations Department, working with the Biosample Operations head to ensure quality and timeliness in the planning, organizing and collection and shipping of biosamples.
• Oversee Records Management, working with the Records Management head to ensure quality in the collection, storage, and tracking of documents for clinical trials. 
• Oversee the establishment and maintenance of inspection readiness across Clinical Operations Organization by collaborating with Quality, promoting excellence in execution and training compliance in the Quality Management System, developing tools to support
• Build capabilities, develop tools and analytical solutions to provide metrics, insights and analys