Director, Outsourcing, Vendor Management and Clinical Contracts

Job Summary:

Nurix Therapeutics, Inc. is seeking a  Director, Outsourcing, Vendor Management and Clinical Contracts to manage full service outsourcing (CRO, Central labs, IVRS, IDMC, IRC, specialty lab sample tracking service) and oversight of site contracts for upcoming Ph2/3 studies.  You will report to the Senior Vice President, Development Operations and work with the clinical development cross functional team, finance, legal and external partners to ensure clinical outsourcing contracts and site contract agreements comply with business best practices and relevant country regulations.

Responsibilities:

• Leading the vendor selection lifecycle including Request-for-Information (RFI) and/or Request-for-Proposal (RFP) activities for clinical services such as study management (CROs), central laboratory, bioanalytical services, interactive response technology (IRT), etc.
• Leading the review and negotiation of budgets for CRO, central laboratory and other vendor agreements on behalf of Clinical Development.
• In collaboration with Legal, negotiating vendor agreements including payment terms in accordance with Nurix standards and processes.
• Developing and maintaining strategic partnerships with key vendors to enable effective collaboration and issue resolution.
• Supporting the budget forecasting activities and quarterly financial reviews with Clinical Operations and Finance.
• Effectively partnering with relevant internal and external stakeholders such as Clinical Operations, Biometrics, Safety, Legal, Regulatory, Finance, Quality Assurance and/or vendors, as applicable, to enable informed, risk-considered decisions.
• Proactively identifying, defining and implementing new or improved Departmental processes or standards.
• Oversight of clinical trial agreements negotiations, master service agreements and other governing documents in accordance with established development timelines.
• End-to-end management of the clinical trial agreement (CTA) process and strategy for global, multi-site clinical trials.
• Partner closely with clinical operations, project leadership and additional functional leaders to understand development priorities to support delivery of negotiated contracts.
• Review established templates for clinical trial agreements, confidentiality agreements, master service agreements, consulting agreements and other development agreements to ensure compliance with country regulations, align with business practices, market competitiveness and incorporate lessons learned.
• Review negotiation playbooks to assess recent escalations in site contracts, update terms following negotiations, ensure alignment with market conditions and to include new country specific regulations.
• Collaborate regularly with Legal for contract approval, execution and assessment of risk.
• Manage the external partnership with the site contract and budget functional service provider. Participation in bi-weekly status meetings, quarterly governance/KPI reviews and facilitate review and execution of annual service work orders.

Experience and Skills:

• BS/MS and 12+ years’ experience in the pharmaceutical or life sciences industry; with extensive experience in clinical outsourcing, vendor governance & relationship management and site clinical contract negotiations.
• 5+ years of experience directly negotiating full scope CRO agreements at task and resource by region level and/or building CRO resourcing models
• Experience with site budget development utilizing fair-market value standards preferred.
• Experience providing clear, practical, and business-oriented guidance on all clinical contracting issues throughout the contracting process
• Knowledge of relevant local and regional regulations
• Experience providing contract support at several stages of clinical trials including start-up, maintenance and close-out
• Knowledge of outsourcing and procurement processes to support contract execution, purchase orders and vendor invoice review 
• Ability to work collaboratively and achieve results in a fast paced environment

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