Associate Director, Outsourcing and Vendor Governance - Vendor Engagement (Office Hybrid or Remote)

Clinical Development Hayward, California Brisbane, California Remote, United States


Description

As an Associate Director, Outsourcing and Vendor Governance team member, you will be responsible for managing and optimizing Vendor Engagement.  The individual will also support outsourcing needs for current and future clinical trials, including vendor identification, RFPs, vendor selection, contract and budget negotiations, budget management. You will work closely with the Clinical Operations and Clinical Development study team, Legal, Finance, and other key internal stakeholders to resolve vendor relationship, contract, and business-related issues. This role is currently reporting to the Director/Senior Director, Outsourcing and Vendor Governance.
Responsibilities
  • Independently manage all outsourcing activities for assigned projects/studies, including (but not limited to) - supplier assessment, RFP/RFQ/RFI, selection, contract budget, payment schedule, payment terms & scope negotiation through to contract execution, and contract life cycle management, as follows:
    • Responsible for management of all global clinical development agreements (work orders, amendments, CDAs/NDAs, ancillary, single-service, HCP agreements, and subcontractor agreements).
    • Negotiate new and amended work specifications, budgets, payment schedules, and payment terms, and ensure service providers adhere to contract terms and conditions. 
    • Guide project teams through the sourcing process and give appropriate suggestions and advice on the best approach/industry best practices.
    • Partner with study team members to manage supplier bidding and proposal development (RFP creation and bid analysis). Facilitate and manage supplier bid defense meetings and associated follow-up.
      • Lead contract-related communication with suppliers. Respond to questions from internal staff regarding the status of contracts. Interact with suppliers on standard contract terms. Appropriately escalates issues and conflicts.
      • Partner with finance and study team members to address financial queries.
    • Demonstrate expanded understanding of legal language to lead contract review and negotiation, as follows:
    • Identify and manage contract risks. Ensure appropriate mitigation plans are in place and use and risks are communicated appropriately to stakeholders.
    • Provide information to stakeholders and leadership management on contract status and contract/finance issues.
    • Ensure agreements comply with company requirements, regarding risk assessment and liability.
    • Respond to and resolves complex issues associated with contracts with support from the appropriate department(s).
    • Manage purchase order process in support of Clinical Development stakeholders and functions.
    • Lead, support, or manage general and ad-hoc projects and departmental activities as required.
    • Partner with Clinical Development functional leads on developing optimized category/function sourcing strategy, sourcing model, and strengthen relationships with selected, qualified vendors.
    • Support initiatives across the outsourcing and vendor governance specialty areas (e.g., vendor set-up and onboarding, vendor governance, metrics and key performance indicators, audit readiness, etc.).
    • Support vendor service cost monitoring and optimization initiatives.
    • Provide direct supervision to colleagues and/or contractors within CC&O.
    • Provide mentorship and guidance to colleagues and/or contractors within the outsourcing and vendor governance.
    • Prepare presentations and train resources and providers on core business requirements.
    • Aid planning and implementation efforts on new strategic sourcing strategies to support cross-organizational vendor spend consolidation, cost savings, vendor performance and productivity, and cycle time reduction.
    • Coordinate with Quality Assurance and the Vendor Oversight Committee (VOC) on new Service Provider onboarding or re-qualification activities to streamline process.
    • Participate in VOC meetings and ad hoc QA meetings.
    • Liaison with QA & VOC on schedule for vendor audits and re-qualification timing.  Collaborate with Vendor Governance AD and report updates at OVG meetings.
    • Lead vendor landscape market research and report industry trends in various forums (e.g.,OVG meetings, LT meetings, etc.).
    • Author request for information (RFI) materials, tools, and guidelines.
    • Drive all RFI requests and non-study related provider capability meetings.
    • Develop vendor performance scorecards and surveys, conduct survey’s, analyze and present findings in relevant forums.  Collaborate with Vendor Governance specialty AD for reporting outcomes.
    • Prepare, manage, and train vendors to clearly communicate Arcus expectations and standards for outsourcing activities including organizing all materials in the central repository (Egnyte).
    • Drive standards for vendor contracts through training, ad hoc reporting, and cost or duration metric evaluations.
    • Perform vendor MSA gap analysis and amend agreements to reflect current Arcus standards.
    • Steer commercial term (discount) vendor negotiations in collaboration with OVG department head.
    Qualifications
    • B.A./ B.S. is required.
    • A MBA is preferred.  
    • At least 10+ years related business/ industry experience.
    • Experience in pharmaceutical, biotech, academia, and CROs (Clinical Research Organizations).
    • Experience in Life Science, Finance, Strategic Sourcing, and/or Business Strategy.
    • Experience with direct reports preferred but not required.
    • Demonstrates In-depth understanding of the drug development process, including clinical trials in phases 1 through 4 and submission, and the related regulatory environment; 
    • Expert knowledge of pharmaceutical sourcing/procurement processes, sourcing models, vendor relationship management, governance, and oversight principles;
    • Insights to current clinical vendor landscape across different vendor categories.
    • Knowledge of audit preparation related to outsourcing activities. 
    • Strong financial acumen. 
    • Extensive experience in vendor selection (including RFI/RFP process), contracting, and budget negotiation. 
    • Experience in vendor management. 
    • Must be a self-starter with minimal supervision. 
    • Ability to work with cross-functional teams and facilitate communication with internal/external stakeholders. 
    • Ability to work with people across varying levels of responsibility within the company and with service providers. 
    • Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively. 
    • Proven ability to analyze and synthesize information to understand issues, identify options, and support sound decision-making. 
    • Excellent computer skills including advanced knowledge in the use of MS Excel, Word, PowerPoint, and Outlook. 
    • Strong organizational and written communication skills with attention to detail. 
    • Able to multi-task and prioritize in a fast-paced environment. 
    • Execute time-sensitive matters while maintaining accuracy, attention to detail, and confidentiality. 
    • Exhibits high self-motivation and ability to work and plan independently as well as in a team environment. 
    • High degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture, and positive interactions with others, including excellent interpersonal skills. 
    • Displays sound business judgment and proactive, independent work style. 
    • Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results. 
    • Works well independently and cooperatively with others to achieve common goals in a virtual environment. 
    • Ability to develop and maintain strong internal and external relationships. 
    • Ability to travel, including overnight stays.

        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 $180,000- $194,000 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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