Director, CRO Excellence and Process Innovation Lead

At Genmab, we are dedicated to building extra[not]ordinary® 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.

Does this inspire you and feel like a fit? Then we would love to have you join us!

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.

For US based candidates, the proposed salary band for this position is as follows:

$0.00---$0.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 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

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!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.