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BeOne MedicinesPosted 2 weeks ago

Senior Director, Global Site Contracts

$206,200–$276,200 year

RemoteUnited States

Full TimeSenior LevelLarge

Job Summary

Lead the global oversight, execution, and continuous improvement of clinical site contracting activities supporting sponsored trials worldwide. Develop and execute the global strategy, governance framework, and operating model for Clinical Site Contracts, ensuring alignment with Global Clinical Operations objectives. Manage the Global Contracts Management team, overseeing policies, procedures, SOPs, and templates while serving as the senior escalation point for complex negotiations. Provide global oversight for all contract agreements, including CTAs, Investigator Agreements, and MSAs, ensuring timely development, negotiation, and close-out to support study startup milestones. Partner with Clinical Operations, Legal, Finance, and CROs to identify contracting risks, implement mitigation strategies, and drive proactive risk reviews against portfolio milestones. Collaborate cross-functionally to resolve issues, maintain effective relationships with investigator sites and vendors, and ensure compliance with ICH-GCP requirements and regulatory standards. Lead ongoing process improvement initiatives to enhance contract cycle times, quality, and operational efficiency through data analysis and workflow optimization.

Required Qualifications

  • scientific and business professionals
  • highly motivated
  • collaborative
  • share our passionate interest in fighting cancer
  • strategic leadership position responsible for the global oversight, execution, and continuous improvement of clinical site contracting activities supporting sponsored clinical trials worldwide
  • leadership for site contract strategy, governance, operational delivery, and process optimization across all regions
  • ensure rapid study startup, compliant contract execution, and high-quality operational performance
  • partners closely with Clinical Operations, Legal, Finance, Global R&D Sourcing, Compliance, CROs, and external institutions
  • establish and maintain scalable contracting processes, global standards, negotiation strategies, and performance metrics
  • drive operational excellence through innovative solutions, standardized methodologies, data-driven decision-making, and strong stakeholder alignment
  • member of the Clinical Business Operations leadership team
  • contributes to organizational strategy, workforce planning, vendor management, and functional transformation initiatives
  • Lead and manage the Global Contracts Management team
  • Oversee activities related to the execution of clinical site contract documents and associated processes
  • Develop and enhance policies, procedures, and systems that optimize contracting operations
  • Ensure compliance, quality, and efficiency across global contracting activities
  • Provide training, mentorship, and supervision to the contracts team
  • Develop and execute the global strategy, vision, governance framework, and operating model for Clinical Site Contracts
  • alignment with Global Clinical Operations (GCO) objectives and portfolio priorities
  • member of the Clinical Business Operations Leadership Team
  • contributing to functional strategy, organizational planning, risk management, and operational excellence initiatives
  • Develop and oversee global governance models, portfolio plans, project plans, and operational frameworks
  • efficient and compliant clinical site contracting activities
  • Determine, implement, and continuously evolve global policies, procedures, SOPs, templates, playbooks, and best practices for site contract management
  • Identify and maintain a globally consistent contract negotiation model
  • balances speed, compliance, quality, and business needs across regions
  • Provide global oversight and accountability for the management of all clinical contract agreements
  • Clinical Trial Agreements (CTAs)
  • Investigator Agreements
  • Confidential Disclosure Agreements (CDAs)
  • Site Master Service Agreements (MSAs)
  • Pharmacy Agreements
  • Ancillary Agreements
  • Consulting Agreements
  • Subcontractor Agreements
  • Other agreements supporting the clinical trial lifecycle
  • Ensure timely development, negotiation, execution, amendment, maintenance, and close-out of global site contracts
  • support of study startup and study conduct milestones
  • Serve as the senior escalation point for complex contractual negotiations, site-specific issues, and institutional contracting challenges
  • Directly participate in high-priority or complex site negotiations when required
  • Maintain oversight of contract quality, compliance, and execution consistency across all regions and programs
  • Partner with Clinical Operations, CROs, and study teams to identify country-, site, and study-specific contracting risks
  • impact startup timelines, enrollment, or study execution
  • Develop and implement proactive risk mitigation strategies to accelerate study startup and reduce contracting delays
  • Conduct regular risk reviews against study and portfolio milestones
  • identifying and escalating potential risks to timelines and deliverables
  • Leverage contracting intelligence, market insights, and operational metrics
  • support study feasibility, planning, and startup execution
  • Provide strategic oversight and guidance on study startup activities and contracting dependencies across the portfolio
  • Collaborate closely with Clinical Operations, Legal, Compliance, Finance, Tax, Procurement, Clinical Outsourcing, and Development stakeholders
  • ensure successful execution of clinical trial contracting strategies
  • Partner with Contract Managers, Legal Counsel, Contract Associates, and Site Contract leaders throughout the contract lifecycle
  • resolve issues and drive timely agreement execution
  • Maintain effective relationships with investigator sites, institutions, CROs, vendors, and strategic partners
  • Communicate contract status, negotiation progress, key risks, and critical path issues to senior leadership and study stakeholders
  • Serve as the primary escalation and decision-making point for complex contract and site budget issues
  • Partner with Site Payments, Finance, and Clinical Operations leaders
  • ensure alignment between negotiated budgets, payment terms, and contractual obligations
  • Lead project review and governance meetings focused on contract performance, financial outcomes, startup effectiveness, and portfolio success
  • Review, analyze, and interpret contract negotiation reports, financial metrics, and operational performance indicators
  • Ensure budget and contract strategies support both business objectives and site relationship needs
  • Oversee governance and performance of contract service providers, FSP partners, CROs, and external vendors supporting clinical site contracting activities
  • Establish and monitor KPIs, SLAs, quality standards, and productivity measures for internal teams and external partners
  • Maintain and strengthen strategic relationships with key internal stakeholders, investigator sites, institutions, and vendors
  • Support enterprise and portfolio-level stakeholder engagement through transparent communication, issue resolution, and operational leadership
  • Drive solution-oriented approaches to address study, site, vendor, and departmental challenges
  • Lead ongoing process improvement initiatives to enhance contract cycle times, quality, scalability, and overall operational efficiency
  • Implement productivity improvements through comprehensive metric collection, reporting, benchmarking, and data analysis
  • Develop and maintain performance dashboards and operational reporting
  • support executive decision-making
  • Partner with Digital Clinical Operations and technology teams
  • optimize contract lifecycle management systems, workflows, automation, and reporting capabilities
  • Champion innovation and continuous improvement
  • support expanding portfolio demands and organ

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