OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a Senior Manager of R&D Outsourcing in Foster City or Santa Monica, CA. The Sr. Manager, R&D Outsourcing role 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. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
• Develops global clinical development vendor strategy for a program or therapeutic area with a focus on Cell Therapy
• 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
• 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
EDUCATION
• BA or MS in a relevant discipline
• MBA or JD preferred
• PMP/CPSM certification or equivalent a plus
To be a best-fit your strengths must include:
• 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
• Flexibility to travel as required
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.