The Senior Manager, Site Budgets and Contracts is accountable for possessing industry experience to enable Clinical Contracts & Outsourcing (“CC&O”) to effectively deliver on business partner goals for all aspects of end-to-end contract operations process (including, contract request validation, contract drafting, negotiation of budget and financial terms, advising of other CC&O team members and functional service provider (“FSP”), and supports internal business partners by helping them to navigate through the contracting process with Health Care Providers (“HCPs”), and academic and research institutions globally. This position will report directly to the Associate Director of Site Engagement & Optimization within the CC&O group.

As Senior Manager, Site Budgets and Contracts you will focus on supporting our internal business partners and site support processes through budget and contract drafting, advising and negotiation using independent judgement and expertise in the legal and financial elements required in a wide variety of research and development contract types, including, clinical trial agreements, investigator initiated studies, and Health Care Provider consulting/fee for services agreements. Additionally, you may be asked to serve as a single point of contact for one/or more internal customer/stakeholder groups, thereby enabling the ClinOps team to deliver consistent high quality results.

Responsibilities

• Provide support and/or leadership on one or more studies
• Provide input on strategy within CC&O; execute program and/or project strategy
• Work with internal/external stakeholders to track site interactions in a timely and accurate manner, ensuring status updates are fully descriptive
• Foster teamwork and a work culture that values collaboration across relevant functions, including, FSP
• Lead end-to-end contract process effort, including, FSP scope of services, clinical study start-up activities, prioritization, operations, and delivery responsibility
• Generate ideas and solutions to improve requested budget/contract changes while partnering with internal/external stakeholders for feedback and execution
• Negotiate clinical site budgets and contracts
• Ensure contract and budget negotiations are authorized and planned following applicable legal and compliance requirements and policies are within limits of delegated/ contractual authority and fair market value.
• Maintain and promote awareness of critical path activities and long lead time deliverables in area of expertise to ensure project timelines are accelerated when possible
• Provide analysis and advice to clinical study teams, business partners, and FSP in negotiations of complex legal and business terms
• Continuously enhance skill at discerning and responding to issues at investigator sites that pose risk, and escalating accordingly
• Discuss and clearly explain complex terms and conditions. Guide other professionals and advise or influence senior business partners. Demonstrate expert knowledge of legal, compliance and/or 3rd party risk management concepts (as applicable) including ability to identify functional area specific risks (e.g., privacy, anti-kickback, Fair Market Value, Sunshine Act, etc.)
• Serve as a subject matter expert on initiatives and working groups, including, serve or be viewed as an emerging in-house expert based on critical contributions in functional an/or technical area
• Ensure the execution of end-to-end process is robust and is established as a way of effectively supporting the needs of key business partners while continuously monitoring and further enhancing service quality, efficiency and effectiveness and lead or support continuous improvement initiatives
• Build competency of FSP to execute the end-to-end process in support of timely site start-up for the conduct of clinical trials, including, accurate forecasting of contract execution timelines
• Responsible for measuring and reporting metrics and Key Performance Indicators (“KPIs”) for in scope service deliverables
• Responsible for ongoing monitoring and mitigation of risks in specific contracting area
• Drive resolution of complex negotiations and contracts
• Ensure operational issue escalation path is clear and managed at the most effective levels, providing coaching and support as required to resolve
• Capture and make accessible relevant contracting service offering documentation and communicate through established stakeholder communities
• Provide content input and delivery support for process specific training to internal and external stakeholders
• Work is performed under minimal (or no) direction
• Establish own work priorities and/or timelines

Qualifications

• A./ B.S., and/ or combination of 8+ years equivalent related business/ industry experience
• Experience in pharmaceutical, biotech, academia, CROs (Clinical Research Organizations)
• Clinical Study Start-up/ management experience
• Demonstrated leadership, stakeholder influencing without authority and negotiation skills
• Strong knowledge of a wide variety of clinical-related contract types, including, clinical trial site agreements, investigator sponsored trial agreements, research collaboration agreements, consulting agreements and confidentiality agreements
• Demonstrated experience with clinical budget development (FMV) and negotiation
• Strong analytical and contract administration skills, verbal and written communication skills, and the ability to interact effectively with internal and external business partners.
• High degree of dedication, motivation, and ability to work under pressure with a drive for results and the ability to engage and deliver through others
• Business level fluency in English
• Additional specialized professional legal, compliance or related certifications highly desirable
• Experience working in global environment
• Skilled facilitator and presenter

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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