Sr. Manager, Development Business Operations, Vendor Outsourcing
Sr. Manager, Development Business Operations, Vendor Outsourcing
United States Remote
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Note: This position can be located in: Foster City, CA or Morris Plains, NJ or Remote
Gilead Sciences is currently seeking an industry leader for Sr. Manager, R&D Outsourcing within our Development Business Operations department. The Sr. 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 Sr. 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 position will have the opportunity to work in a matrix environment and regularly collaborate with Senior Management and cross functional teams.
The core responsibilities and skills required for this position include but is not limited to:
Leadership and Management
- Manages operational functions including, supervising other staff who contribute to clinical contract management.
- Participates in establishing departmental and cross-functional policies and procedures
- Impacts the business results of related teams by setting priorities, allocating resources, and developing policies and plans
- Is accountable for the performance and results of a team
- Interprets, executes and recommends modifications to operating policies and procedures
- Adapts group plans and priorities to address resource and operational challenges
- Accountable for developing talent through on-going performance feedback and career management coaching
- 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
- Develops and implements sourcing strategies to support given scope
- 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 for a program or therapeutic area
- Is an SME in resolving complex issues relating to contract negotiation and management
- Oversees the identification, selection and management of global external service providers
- Leads Vendor bid defense meetings
- Manages the contract negotiation process for complex or high value contracts
- Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development
- 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
- 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
- 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
- Translates trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up
Influence and Partnership
- Engage with clinical operations leadership to drive sourcing strategy, compliance, and continued 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
- Delivers value by developing business solutions by translating requirements into effective sourcing solutions, contractual terms and process improvements
- Demonstrated ability to make critical 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
- 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
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 an in-depth knowledge of the clinical research process and the regulatory environment across functions
- 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:
- 8+ years of experience with a BA in a relevant discipline.
- 6+ years of experience with a MS in a relevant discipline.
- Relevant experience with a BA or MS in a relevant discipline
- MBA or JD preferred
- PMP/CPSM certification or equivalent a plus
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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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:
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