Director, Contract Optimization and Strategy Team (COST)

The Opportunity:

The COST-Vendor Director leads the end-to-end outsourcing of one or more indications and supports governance of external service providers for current and future clinical trials for multiple Development functions, with a strong emphasis on Clinical Vendors (e.g., CRO’s, imaging, cardiac, IRT, data management, Pharmacovigilance, etc.) Responsibilities include partnering with the clinical operations and other functional teams for clinical vendor identification, creation of requests for information/proposal (RFIs/RFPs), service provider selection, contract negotiations, budget and contract lifecycle management, and facilitating service provider governance, including Key Performance Indicators (KPIs) and performance metrics. This position would report to the Senior Director, COST Vendor Team.  The key responsibilities are:

• Lead through development of tools and methods in driving business needs through delivery of quality vendor contracts, budgets, and proposals.

• Accountable for development and cultivation of excellent internal cross-departmental and external service provider relationships that enable advancement of clinical development programs.

• Oversee and drive the negotiation of initial scopes of work and related changes, including budgets, and payment schedules, with input from cross-functional stakeholders, for service providers.

• Oversee budget reconciliation.

• Negotiate change orders and ensure service providers adhere to contract terms.

• Generate RFIs, RFPs and budget grids/trackers for clinical trials and assist Clinical Development Management with the service provider selection process including bid comparison analysis.

• Coordinate bid defenses and proposal review meetings.

• Partner with Clinical Quality Assurance (CQA), Information Sciences (IS) and relevant functions to ensure all selected vendors are qualified and IS Security Assessments conducted, according to SOPs and business processes.

• Manage contract lifecycle in collaboration with legal department.

• Help organize and participate in vendor governance meetings and reviews.

• Maintain market intel (rates, KPIs) and recommend sourcing approaches.

• Collaborate internally and with vendors to develop and report service provider performance via Key Indicators, including Performance, Risk, Quality and Financial (KPIs).

• Partner with departments to create standardized KxIs per vendor type.

• Partner with departments to create clinical trial budgeting models and scenarios.

• In partnership with management, contribute to the audits of contract and sourcing records to ensure accuracy and completeness.

• Contribute to the development, improvement and implementation of processes and tools related to outsourcing and governance activities.

• With the support of RevMed’s legal counsel, manage the contract negotiation process.

• Manage general and departmental ad hoc projects as required.

• Manage and oversee direct reports.

• Other duties as assigned.

Required Skills, Experience and Education:

• BA/BS in related discipline with at least 15 years of related experience required (a combination of relevant education and applicable job experience may be considered).

• At least 9 years in a management role overseeing individuals in a high performing team environment.

• Minimum of (10) years of direct clinical business operations experience/outsourcing and vendor governance in a CRO, Biotech or Pharmaceutical organization.

• Solid understanding of drug development and development operations, with experience working with Clinical and/or Toxicology laboratory vendors highly desired.

• Ability to prepare/negotiate and track external provider master service agreements, work/change orders, etc.

• Must demonstrate an understanding of vendor budgets and payment terms

• Experience in RFI/RFP development, proposal evaluation, and contract and budget management.

• Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.

• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint and Outlook.

• Must be a self-starter who drives cross-department relationships, has backbone and helps the organization hold external service providers accountable to contracted work.

• Works effectively in a matrix cross-functional environment.

• Good business judgment and a strong understanding of the unique aspects of clinical financials.

• Excellent communication skills, (verbal and written), and critical thinking skills, including the ability to understand and present budget information effectively.

• High sense of accountability/urgency.

Preferred Skills:

• Familiarity working with financial and legal systems/portals.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

• Working knowledge of applicable regulatory, ICH and GCP.

• Grant Plan or Grant Manager experience.

• Global Project Level Budget Builds.

• Advanced knowledge of Microsoft Word, Excel, PowerPoint and Smartsheet. 

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