Director, Team Lead, Clinical Data Management

The Role

The Director, Team Lead, Clinical Data Management, is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning and timely delivery of complete, high quality and reliable clinical trial data. The Director, DM will provide oversight to ensure that end-to-end data management activities are consistent across the portfolio. The employee will also provide input to/support Genmab clinical drug development programs to ensure data management excellence.

In the role of Team Lead, the employee will be responsible for managing, coordinating, developing, supervising and supporting the employees in Clinical Data Management and ensure that the employees competencies reflect their responsibilities, as outlined in their job descriptions. The Team Lead will be part of the Data Management Leadership Team which defines the overall strategy, unified objectives, and areas for development of Data Management.

Responsibilities

• Compound(s) oversight of a team of trial data managers to ensure successful delivery of DM deliverables to meet company objectives

• Contributes to and drives the strategic direction of the Clinical Data Management functional area

• Contributes to the overall strategy, unified objectives, and areas for development of Development Operations

• Ensures data management activities and processes support the efficient and effective execution of clinical trials

• Drives development of systems and processes within Data Management

• Ensures end-to-end data management consistency across the portfolio

• Responsible for driving the selection, collaboration and oversight of vendors related to data management activities

• Establishes relevant processes to ensure oversight of data management vendor partners

• Develops and maintains expert competences within Data Management

• Acts as a role model

• Proactively engages in department activities

• Arranges lessons learned to share learnings

• Leads various initiatives within the department and across departments

• Proactively contributes to support a global organization

• Acts as mentor for junior/new employees or consultant

• Participates in audits and inspections, as applicable

Requirements

• Bachelor's degree in science or related area (or equivalent); Master’s or Advanced Degree preferred

• 12+ years of experience in clinical data management experience in biotech/ pharma industry; significant end-to-end, hands-on experience in all aspects of data management. Experience within all phases of oncology trials preferred.

• Significant experience working with clinical trials and the drug development process

• Significant experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in complex oncology trials

• Significant experience working on early and late-stage submissions as per local/regulatory requirements

• Significant experience leading data management activities for clinical trials; advanced use of data management systems; expert knowledge of DM processes, tools, methodologies and documentation; expert understanding of DM strategy

• Significant experience of GCPs, SOPs, regulatory requirements and good data management practices

• Significant experience working on early and late-stage submissions as per local/regulatory requirements

• Significant experience in working with Clinical Data Standards in clinical oncology trials according to regulatory requirements (FDA, ICH)

• Significant experience with CDISC (SDTM) as well as data collection requirements in oncology trials

• Significant experience in working with and leading cross-functional teams

• Experience leading/guiding/mentoring a functional team

• Experience in budget management

• Direct experience with EMA, FDA, and PMDA inspections preferred

The role is located in Copenhagen DK, or Utrecht NL or US (Remote)

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.