Director, CRO Excellence and Process Innovation Lead

About the position At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. If you have a passion for vendor oversight and process improvement within clinical trial operations, then this role is for you. This is an office-based hybrid position with the expectation to be onsite at least 60% of your time to foster collaboration and team engagement.

Responsibilities

• Support the execution of outsourced Phase I-III clinical trials through direct oversight of CROs and functional service providers.
• Ensure vendor delivery aligns with program timelines, budgets, and quality expectations.
• Serve as a key point of contact for vendor-related operational issues, escalating unresolved matters as needed through the escalation pathway and governance structure.
• Manage and maintain operational relationships with CROs, including adherence to governance frameworks and partnership operational manuals.
• Participate in vendor governance forums such as Operational Committee meetings and provide input into Steering Committee discussions.
• Contribute to CRO performance evaluations and facilitate resolution of operational issues.
• Identify opportunities to improve outsourcing processes and contribute to the development and rollout of new operational best practices.
• Collaborate with Development Operations/Trial Operations and other functional groups to streamline trial delivery and reduce operational inefficiencies.
• Support process mapping, documentation, and implementation of continuous improvement initiatives.
• Act as a mentor and resource to Global Trial Leaders/Clinical Trial Managers and other team members involved in vendor oversight.
• Provide input into team development efforts, including training and knowledge sharing related to outsourcing and governance practices.
• Collaborate cross-functionally to align outsourcing strategy execution and process standards.
• Work closely with colleagues in Clinical Strategy, Development Operations, Regulatory Affairs, and external partners to align operational execution with clinical development goals.
• Foster collaborative relationships with vendors to ensure transparent communication and proactive issue management.
• Ensure vendor-conducted activities are compliant with ICH-GCP, regulatory requirements, and internal SOPs (where applicable).
• Monitor and support alignment between vendor processes and Genmab's quality systems.
• Participate in audits and inspections as needed, ensuring preparedness of outsourced trial components.

Requirements

• 10+ years in clinical trial operations, with experience in vendor/CRO oversight and outsourcing governance.
• Bachelor's degree in life sciences, healthcare, or related field (advanced degree preferred).
• Strong understanding of clinical trial processes, ICH-GCP, and regulatory standards.
• Proven experience managing CROs and functional vendors across global studies.
• Demonstrated ability to identify operational inefficiencies and contribute to solution development.
• Ability to work in matrixed environments and foster productive cross-functional partnerships.
• Excellent organizational, interpersonal, and communication skills.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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