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Manager, R&D Outsourcing

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: November 27, 2022

Job Description:

Gilead Sciences is currently seeking an industry leader for Manager, R&D Outsourcing within our Development Business Operations department. The Manager will have the opportunity to provide category management, sourcing and contracting expertise in clinical outsourcing of global Phase 1b-Phase 3 clinical trials. The Manager will lead the entire life cycle including vendor selection, RFI, RFP, vendor selection decision, contracting, monitoring performance, change orders and ensuring proper closeout of clinical agreements, with a focus on Clinical Research Organizations (CRO). The Manager should have deep experience in the CRO industry and thorough understanding of CRO contracting, budgeting and negotiation processes. The position will have the opportunity to work in a matrix environment.

The core responsibilities and skills required for this position include but is not limited to:

Delivery Excellence

  • Develops global clinical development vendor strategy for a program or therapeutic area
  • Manages contract and sourcing activities for Phase 1b-3 clinical development programs providing consistent customer service and delivering quantitative value through cost savings and transformation/innovation
  • Manages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings
  • Ensure the vendor selection process is compliant by managing risks through benchmarking, rate negotiations, implementing the sourcing strategy, collaborating with cross functional teams such as Compliance, Legal and Regulatory
  • Collaborates with internal customers in vendor bidding and proposal development (RFP creation and analysis)
  • Partners with internal customers to develop study specifications and leverages benchmarking tools as appropriate
  • Translates business requirements into vendor capabilities and develops recommendations for vendor selection
  • Oversees the identification, selection and management of global CRO's
  • Assists with vendor bid defense meetings
  • Manages the contract negotiation process for moderately complex contracts
  • Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development
  • Manages contract activities for multiple clinical development programs, ensuring there are adequate staff with the skills to complete Development Operations contracts accurately, consistently and in a timely manner.
    Strategic Thinking
    • Ability to understand, analyze and develop recommendations from multiple complex sources such as financial and operational perspectives
    • Influence vendor selection with stakeholders at the project team level
      Innovation
      • Identifies, develops, and deploys best practices in vendor selection, cost containment, and category management practices
      • Leverages prior experience with external benchmarking, industry best practices, and technology for continuous improvement
        Problem Solving
        • Takes ownership of issues from problem identification to successful resolution, testing recommendations for reasonableness
        • Triages study-level vendor management issues; escalates high-risk issues to appropriate stakeholders
          Influence and Partnership
          • Exhibits competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance
          • Partners with internal stakeholders working on contracts in resolving complex issues relating to contract negotiation or management
          • Manages study level vendor relationships in conjunction with Clinical Operations
            Decision Making
            • Delivers value by developing business solutions by translating requirements into effective sourcing solutions, contractual terms and process improvements
            • Demonstrated ability to make decisions related to clinical vendor agreement negotiations and escalations
            • Pulls data across functions according to business requirements and recommends global development vendors to senior leadership for endorsement for a project
            • Asks probing questions to uncover business needs and recommends solutions (e.g., negotiating timelines while maintaining standards)
            • Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols
            • Identifies operational and systematic issues, including frequency and escalates to the appropriate level
              Communication
              • Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members
              • As necessary, trains internal stakeholders in contract budgeting, development, and administration
              • Manages study level vendor relationships in conjunction with the Vendor Relationship Management and Development Operations groups.
                Capabilities and Requirements
                • Experience in providing thought leadership and consistent customer service
                • Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and management
                • Demonstrates strong understanding of the clinical research process and the regulatory environment
                • Ability to manage multiple competing priorities and effectively communicate expectations
                • Demonstrated leadership skills while working in fast paced and changing environment
                • Financial acumen to review, analyze and understand cost drivers of complex budgets
                • Legal, clinical operations and regulatory acumen
                • Travel may be required
                  Knowledge, Experience and Skills:
                  • 7+ years of experience with a BA in a relevant discipline.
                  • 5+ years of experience with a MS/MBA in a relevant discipline.
                  • Relevant experience typically includes contract negotiation and/or clinical finance
                    For jobs in the United States:
                    As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

                    Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

                    For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

                    NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
                    YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

                    PAY TRANSPARENCY NONDISCRIMINATION PROVISION

                    Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

                    Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

                    For Current Gilead Employees and Contractors:
                    Please log onto your Internal Career Site to apply for this job.

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Keywords: Gilead Sciences, Inc., San Mateo , Manager, R&D Outsourcing, Executive , San Mateo, California

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