The Associate Director, Site Contract Management, provides operational leadership to a global team of Site Contract Managers. The role oversees the end-to-end management of Clinical Trial Agreements (CTAs) and other site contracting documents, including negotiation, FMV, and site payments, ensuring compliance with legal and regulatory standards. Acting as a key link between Legal, Compliance, Development Operations and Finance, the position drives contracting efficiency, consistency, and quality. The Associate Director oversees team performance, process optimization, and delivery of timely, audit-ready site contracts that support Genmab’s clinical development objectives. May require occasional domestic and international business travel.
Key Accountabilities
- Leadership and People Management Provides direction and leadership to a team of Site Contract Managers, ensuring effective performance, engagement, and professional development. Oversees resource allocation and prioritization to meet operational needs and foster a culture of accountability, collaboration, and continuous improvement.
- Strategic Oversight of Site Contracting Leads and manages the full lifecycle of Clinical Trial Agreements, including negotiation, FMV benchmarking, execution, and amendments. Drives standardization and efficiency through the implementation of process optimization strategies and ensures adherence to global policies, templates, and processes to support timely study start-up.
- Legal, Regulatory, and Compliance Alignment Partners with Legal, Compliance, and Finance to ensure all site contracts meet legal, regulatory and compliance requirements. Maintains audit-ready documentation, proactively identifies risks, and ensures seamless integration of evolving legal and regulatory expectations into daily operations.
- Stakeholder Management and Cross-functional Collaboration Acts as the main escalation point for complex negotiations and fosters strong partnerships with Clinical Operations, Legal, Compliance, and Finance stakeholders. Ensures transparent communication of progress, risks, and performance metrics to internal stakeholders and senior leadership.
- Operational Excellence and Performance Management Defines and monitors KPIs for site contracting operations to ensure quality, compliance, and timely delivery. Leads continuous improvement initiatives and process optimization while supporting the development of SOPs, tools, and templates to enhance global consistency.
- Inspection Readiness and Quality Assurance Ensures all contract-related documentation is accurate, complete, and inspection-ready. Supports audits and inspections, drives CAPA implementation, and promotes a strong culture of compliance, quality, and data integrity within the team.
Qualifications/Experience
- Bachelor's Degree
- 10+ years of direct experience in Site Contracting, FMV Benchmarking, and Site Payment tools and processes within the biotechnology, pharmaceutical, CRO, or healthcare industry
- 3+ years people management experience
- Substantial knowledge with GCP, ICH, Regulatory, and relevant FDA/EMA guidelines
- Fluent in spoken and written English
- Excellent stakeholder management, concise written and verbal communication, ability to influence, clearly communicate and collaborate across an increasingly complex matrix environment. Demonstrate advanced skills in Microsoft Office applications (Excel, Word, PowerPoint, Outlook), SAAS-based platform tools and other industry standard programs
Attributes of a successful candidate
- Self‑starter; motivated by working in a fast‑paced, ambiguous environment
- Detail oriented, timeline driven and ability to work in a structured environment as an individual and team contributor
- Applies innovation and compliance mindset to process evaluation and improvement
- Analytical approach to identifying relevant metrics, and defining meaningful KPIs
- Demonstrates self‑awareness and ability to receive and provide constructive feedback for development
About You
- You are genuinely passionate about our purpose
- You bring precision and excellence to all that you do
- You believe in our rooted‑in‑science approach to problem‑solving
- You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
- You take pride in enabling the best work of others on the team
- You can grapple with the unknown and be innovative
- You have experience working in a fast‑growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so!