Director, CRO Excellence and Process Innovation Lead

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.

Job Description:

The Director of CRO Excellence and Process Innovation Lead will play a key operational role in supporting the execution and refinement of the clinical outsourcing model across the development portfolio. This position will focus on the day-to-day oversight of CRO performance, vendor relationship management, governance processes, and the implementation of process improvement initiatives to enhance trial delivery.

Reporting to the Senior Director, Head of CRO Excellence and Process Innovation within TSD .

Key Responsibilities:

Operational Oversight

• 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 .

Vendor Management

• 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.

Process Optimization

• 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.

Team Support and Collaboration

• 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.

Cross-Functional Partnership

• 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.

Compliance and Governance

• 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.

Qualifications:

• Experience : 10+ years in clinical trial operations, with experience in vendor/CRO oversight and outsourcing governance.

• Education : Bachelor’s degree in life sciences, healthcare, or related field (advanced degree preferred).

• Knowledge : Strong understanding of clinical trial processes, ICH-GCP, and regulatory standards.

• Vendor Management : Proven experience managing CROs and functional vendors across global studies.

• Process Improvement : Demonstrated ability to identify operational inefficiencies and contribute to solution development.

• Team Collaboration : Ability to work in matrixed environments and foster productive cross-functional partnerships.

• Communication : Excellent organizational, interpersonal, and communication skills.