Overview
This role is a Senior Director, Global Site Contracts leadership position responsible for global oversight, execution, and continuous improvement of clinical site contracting activities supporting sponsored clinical trials worldwide. The position provides leadership for site contract strategy, governance, operational delivery, and process optimization across all regions to ensure rapid study startup, compliant contract execution, and high-quality operational performance.
The role partners with Clinical Operations, Legal, Finance, Global R&D Sourcing, Compliance, CROs, and external institutions to establish scalable contracting processes, global standards, negotiation strategies, and performance metrics.
As part of the Clinical Business Operations leadership team, this individual contributes to organizational strategy, workforce planning, vendor management, and functional transformation initiatives that support the evolving needs of the clinical development portfolio.
Responsibilities
- Lead and manage the Global Contracts Management team.
- Oversee execution of clinical site contract documents and associated processes.
- Develop and enhance policies, procedures, and systems to optimize contracting operations.
- Ensure compliance, quality, and efficiency across global contracting activities.
- Provide training, mentorship, and supervision to the contracts team.
Essential Functions
Strategic Leadership & Functional Governance
- Develop and execute the global strategy, vision, governance framework, and operating model for Clinical Site Contracts, aligned with Global Clinical Operations (GCO) objectives and portfolio priorities.
- Contribute to functional strategy, organizational planning, risk management, and operational excellence initiatives as a member of the Clinical Business Operations Leadership Team.
- Develop and oversee global governance models, portfolio plans, project plans, and operational frameworks supporting 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.
- Maintain a globally consistent contract negotiation model balancing speed, compliance, quality, and business needs across regions.
Global Site Contract Lifecycle Management
- Provide global oversight and accountability for management of clinical contract agreements, including:
- 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 in 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.
Study Startup Strategy & Risk Management
- Partner with Clinical Operations, CROs, and study teams to identify country-, site, and study-specific contracting risks that could 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.
- Use contracting intelligence, market insights, and operational metrics to support study feasibility, planning, and startup execution.
- Provide strategic oversight and guidance on study startup activities and contracting dependencies across the portfolio.
Cross-Functional Collaboration
- Collaborate with Clinical Operations, Legal, Compliance, Finance, Tax, Procurement, Clinical Outsourcing, and Development stakeholders to support execution of clinical trial contracting strategies.
- Work with Contract Managers, Legal Counsel, Contract Associates, and Site Contract leaders throughout the contract lifecycle to resolve issues and drive timely agreement execution.
- Maintain 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 on a regular basis.
- Act as the primary escalation and decision-making point for complex contract and site budget issues.
Site Budget & Financial Oversight
- Partner with Site Payments, Finance, and Clinical Operations leaders to 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.
Vendor & Client Relationship Management
- 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.
Operational Excellence & Continuous Improvement
- Lead 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 to support executive decision-making.
- Partner with Digital Clinical Operations and technology teams to optimize contract lifecycle management systems, workflows, automation, and reporting capabilities.
- Support innovation and continuous improvement to meet expanding portfolio demands and organizational growth.
Compliance, Quality & Regulatory Oversight
- Ensure compliance with applicable regulations, ICH-GCP requirements, company policies, legal standards, and industry best practices.
- Stay current on evolving global regulatory, legal, and compliance requirements impacting clinical site contracting activities.
- Provide guidance to internal stakeholders and external partners regarding regulatory and contractual requirements as appropriate.
- Ensure inspection readiness, audit preparedness, and adherence to quality standards across the Clinical Site Contracts function.
Supervisory Responsibilities
- Lead, mentor, and develop a global organization of Site Contract professionals.
- Provide supervisory oversight including recruitment, onboarding, training, coaching, performance management, succession planning, workload balancing, resource allocation, and career development.
- Build and evolve the organizational structure required to meet current and future business needs.
- Ensure departmental productivity, performance targets, staffing requirements, and service levels are achieved.
- Foster a culture of accountability, collaboration, innovation, inclusion, and continuous learning.
Requirements
- Experience providing global oversight and leadership for clinical site contracting activities in support of sponsored clinical trials.
- Demonstrated ability to develop and implement global governance models, policies, procedures, and SOPs for site contract management.
- Experience managing clinical contract lifecycle activities, including development, negotiation, execution, amendments, maintenance, and close-out.
- Ability to serve as a senior escalation point for complex contractual negotiations, site-specific issues, and institutional contracting challenges.
- Strong cross-functional collaboration experience across Clinical Operations, Legal, Compliance, Finance, Tax, Procurement, Clinical Outsourcing, and Development stakeholders.
- Demonstrated ability to oversee contract performance, financial outcomes, and related operational metrics.
- Strong understanding of compliance and quality requirements, including ICH-GCP.
- Experience with performance management and team leadership.
Preferred Qualifications
Compensation & Benefits
- Salary Range: $206,200.00 - $276,200.00 annually.
- Actual compensation packages are determined by job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
- Non-Commercial roles are eligible to participate in the annual bonus plan; Commercial roles are eligible to participate in an incentive compensation plan.
- Employees are eligible for discretionary equity awards and may voluntarily participate in the Employee Stock Purchase Plan.
- Comprehensive benefits package includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
Location
Not specified.
Equal Opportunity Employment
An equal opportunity employer. Employment decisions are based on qualifications, merit, and business need. Reasonable accommodation is available for individuals protected by applicable federal, state, and local laws.