Description

The Director of Business Operations, Clinical Operations, is responsible for managing key business operations within the Clinical Operations department. This role includes overseeing and optimizing of critical business processes, including systems, related to clinical trial planning and execution, supporting inspection readiness, and training and onboarding for Clinical Operations. The Director will collaborate cross-functionally with internal stakeholders to drive operational efficiency, ensure compliance with regulations, and contribute to continuous improvement initiatives. This position reports to the Head of Business Operations and Enablement, Clinical Operations. This position is remote or if bay area in-house/hybrid, depending on experience.

Responsibilities

Support the identification and implementation of process improvements to optimize clinical trial execution in collaboration with Clinical Program Directors and Clinical Operations Functional Leads.
Serves as the Subject Matter Expert on process improvement projects and compliance with timelines to achieve desired outcomes inside the Clinical Operations Organization and outside.
Assist in the development, maintenance, and optimization of Clinical Operations’ standard operating procedures (SOPs) and ensure alignment with industry regulations.
Coordinate operational excellence initiatives, such as process standardization, efficiency improvements, and best practices implementation.
Assist in training and onboarding efforts for Clinical Operations personnel, ensuring training programs align with business needs and compliance requirements.
Partner with study teams to support vendor oversight processes, including the development and review of Vendor Oversight Plans.
Facilitate clinical site oversight initiatives, including the creation, execution, and documentation of oversight visits.
Lead and support the implementation and maintenance of electronic systems utilized within Clinical Operations, including CTMS, eTMF, learning management system, sample inventory, etc.
Contribute to inspection readiness efforts by collaborating with Quality and supporting process compliance and documentation initiatives.
Manage CAPA/ Process improvements that come out of internal audits and providing recommendations and implementing applicable remediation tactics.
Assist in managing external relationships related to Clinical Operations, including CROs, vendors, and strategic partners.
Support cross-functional collaboration with departments such as Regulatory, Clinical Supply, Quality, and Data Management to enhance overall trial execution.
Represent Clinical Operations in internal meetings, working groups, and initiatives, providing input on process improvements and strategic business decisions.
Responsible for line management and career development of Senior/ Managers, Business Operations or other roles in Clinical Operations. Provide guidance to Business Operations team members, supporting their career development and day-to-day responsibilities.
Supporting Head of Business Operations and Enablement, Clinical Operations, attending meetings as requested, running meetings, planning and executing offsites, and presenting to executive leadership.

Qualifications

Bachelor’s or Master’s degree in a life sciences discipline, plus 10+ years of experience in clinical drug development (8+ yrs with Master’s), including 3+ years in a Clinical Operations business operations or project management role.
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 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 International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines.
Proven experience in vendor management, including contract and financial oversight.
Ability to manage multiple projects simultaneously with attention to detail while maintaining a strategic perspective.
Strong problem-solving skills and ability to drive process improvements.
Excellent verbal and written communication skills.
Strong organizational and project management skills, with the ability to prioritize and meet deadlines.
Proficiency with project software including Excel, Microsoft Project, and/ or Smartsheet.
Experience with Veeva suite of Vaults (clinical, quality, RIM) preferred.
Experience in training and process improvement preferred.

Other

Travel: Some domestic and international travel may be required (~10-25%).

Physical Requirements Office Setting

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.

This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $215,000 - $240,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers .

EOE

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

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Arcus Biosciences Jobs

Director of Business Operations, Clinical Operations (Office OR Remote)