Vice President, Business Enablement - Clinical Operations

Arcus Biosciences•Hayward, CA

21d•Hybrid

About The Position

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.

Requirements

Bachelors, Masters, or Doctorate degree in life-sciences discipline plus 12+ years of progressive experience in clinical drug development, including 10+ years of Clinical Operations line management experience.
Domestic and international clinical trial execution experience required.
Experience and expertise in the conduct and execution of end-to-end global clinical trials, including process and experience within one or more key functions is required.
Working knowledge of clinical trial systems (CTMS, IRT, EDC, eTMF) is required.
Experience working in a matrix environment with other functional groups (e.g. Regulatory, Clinical Supply, Data Management, Quality) where consensus across multiple opinions and good working relationships are important.
In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Ability to manage early phase clinical programs, through regulatory filing.
Demonstrated track record of successfully developing and executing on clinical development plans (CDP).
Proven ability to build strong relationships with external partners, CROs, and vendors including experience managing contracts and clinical finance activities.
Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
Must be willing and possess the expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate.
Flexible to accommodate changes in team and project needs.
Analytical thinker with excellent problem-solving skills.
Excellent interpersonal, verbal, and written communication skills.
Excellent planning, organization, and project management skills.
Ability to make independent, timely and appropriate decisions.
Proficiency with project software including Excel and Microsoft Project.

Nice To Haves

Experience with Veeva suite of Vaults (clinical, quality, RIM) preferred.
Experience in training and process improvement preferred.

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 analysis of clinical trials.
Oversee the development and management of the Clinical Operation Organization’s SOPs and partner with subject-matter experts to modify and improve upon existing SOPs when required. Establish and oversee change management process within the Clinical Operations Organization. Lead operational excellence initiatives within the Clinical Operations Organization.
Develop a culture of learning and continuous improvement by leading and supporting the identification and implementation of training needs for the Clinical Operations team, including the Clinical Operations training curriculum.
Oversee the selection, implementation, and ongoing maintenance of electronic systems used by the Clinical Operations Organization.
Oversee CAPA/ Process improvements in the Operations Department as a result of internal/external audits and providing recommendations and implementing applicable remediation tactics.
May represent Clinical Operations role in company/function initiatives and regularly contribute to the optimization of existing as well as the development of new processes and resources.
Supporting Sr. Vice President, Clinical Operations, attending meetings as requested, running meetings, planning and executing offsites, and presenting to executive leadership.
Responsible for line management and career development of sub function leads within the Business Operations department.