Clinical Program Demand Lead: Provide strategic program/project management leadership to ensure clinical teams efficiently source and contract appropriate Phase I – IV clinical service vendors. This includes developing sourcing plans to ensure proper selection and management of program/study level vendors. Collaborate with study teams to understand study demands, timelines and specifications. Plan and communicate study timelines and specifications to procurement team for contract negotiation/execution. Act as primary liaison between the clinical and procurement team to ensure contract timelines, quality and cost efficiencies are realized. Lead process development initiatives, create/update study/contract trackers, run planning/forecasting metrics, design/develop Guidance Documents, Quick Reference Cards, training slides and supplemental material.

Clinical Program Demand Lead: Develop program and study level outsourcing plans to ensure proactive management of vendor outsourcing needs and identification of new vendor services. Ensure study teams follow a program outsourcing plan which maximizes the use of preferred and qualified vendors. Identify and communicate potential sourcing/contracting risks to Study Management Team (SMT). Act as primary liaison between SMT and Procurement to ensure program/study level contracts are executed and maintained to meet operational needs.

Manage Vendors, budgets and contracts related to initial start-up, ongoing, close-out and final reconciliation of Phase I to IV Clinical Services. Leads evaluation and selection of Vendors for ECG, Imaging, CRO, Web Portal/Training, Drug Supply & Logistics, Health Economics and Outcomes Research, Home Nursing, ePRO, iRT, Laboratory, Meeting Planning, Patient Recruitment & Retention, Scientific Collaboration, Site Equipment, Translation Services. Work closely with legal, clinical operations, and other relevant functional groups for review and escalation of contract and budget issues.

Provide support to the business within the Enterprise-wide R&D category; manage corporate relationship and performance of clinical vendors contracted to perform services or provide goods in support of clinical trials. Liaise with vendors, corporate services, project teams and functional area representatives to support quality initiatives and other client deliverables. Provide support that will effectively meet the needs of the business and deliver maximum value; this includes sourcing, contracting, decision-making/problem-solving and project-specific supplier management activities.

Manage contracts for multimillion dollar pharmaceutical drug clinical studies conducted in the Americas, Europe, Africa, and AsiaPacific regions. Primary lead/interface on key Enterprise and Development Pharmaceutical Client Accounts; Create Work/Change Orders and work with Strategic Pricing and Business Development teams to determine adequate service budget pricing; Develop and maintain contract client instructions and tracking logs of open items; Build relationships with contracts, sales, proposals, finance and project management teams; Manage internal systems and tracking tools that capture information on team assignments, contract negotiations, process improvement, timesheets, and project planning; Triage global contracts workload assignment mailbox and QC contracts/budgets for the team; Maintain Salesforce CRM, BOX etc systems for management of contracts.

Work with Pharmaceutical Companies, Project Management, and Business Development Teams in the Americas, Europe, Africa, and AsiaPacific regions to develop contracts that enable the execution of Clinical Trials. Work with Finance Team to ensure that revenue recognition is accurate, timely and in accordance with contract terms.

Analyze RFPs and prepare budgets/proposals for multimillion dollar pharmaceutical drug clinical studies; Collaborate with Proposal Development, Contracts Management, Business Development, Project Management and Scientific Teams to ensure deliverables meet Pharmaceutical Clients’ specifications.

Ensure Pharma/Biotech companies are compliant with Emory's license agreement terms; Perform royalty audits for biomedical/other licensed technology; Review licensee progress reports to determine if licensee is developing licensed technology on schedule. Review licensed product sales reports submitted to Emory against those reported to the public & SEC. Ensure Emory’s compliance with federal & non-federal funding obligations. Manage multiple compliance projects involving patent protection & licensing of biomedical inventions.

Liaise with Emory’s inventors, licensing associates, licensees & patent lawyers to ensure strategic patenting & licensing of Emory’s inventions to maximize technology licensing revenues; Ensure Emory's compliance with federal (Bayh-Dole Act) & non-federal research funding statutes; Prepare non-confidential technology summaries to identify & foster out-licensing opportunities; Review, approve or contest legal accounts payable from Emory’s biomedical patent prosecution lawyers.

Triage biopharmaceutical, diagnostic, medical device & software inventions for commercialization potential; Review, docket, track & file invention disclosures & patent-related documents; Develop & oversee the drafting, negotiation & execution of license agreements; Direct all aspects of invention reporting as per federal (Bayh-Dole Act) & non-federal contractual statutes.