An Associate Director, 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 Associate Director DM will provide oversight to ensure end-to-end data management consistency across the portfolio. The employee will also provide input to Genmab clinical drug development programs to ensure data management excellence.

Responsibilities:

• Contributes to and implements the strategic direction of the Clinical Data Management functional area
• Contributes to the overall strategy, unified objectives and areas for development of Clinical Operations
• Ensures data management activities and processes support the efficient and effective execution of clinical trials.
• Ensures trial related data management activities (including planning, data collection, data cleaning and database lock activities) are performed in accordance with Genmab SOP/processes and standards and ICH-GCP
• Provides oversight of DM CRO including Statement of Work, budget, KPIs, and performs other DM CRO oversight activities
• Leads/contributes to standardization activities across the portfolio.
• Drives/contributes to the development of systems and processes within Data Management
• Ensures end-to-end data management consistency across the portfolio
• Contributes to vendor selection; ensures collaboration and oversight of vendors related to data management activities
• Drives/supports vendor qualification (Request for proposal, bid defense meetings etc.) for data management related activities and defines/specifies scope of work for functional tasks
• Establishes relevant processes to ensure oversight of data management vendor partners
• Participates in audits and inspections, as applicable
• Ensures timely response to audits/inspections including carrying out a comprehensive root cause analysis and share learnings across trials as applicable
• Develops and maintains advanced competences within Data Management. Follows scientific, process and technical progress within the field of clinical data management and advises of new methodologies that may support innovation and improve efficiencies
• Proactively engages in department activities
• Arranges lessons learned to share learnings
• Leads/participates in various initiatives within the department and across departments
• Proactively contributes to support a global organization

Requirements:

• Bachelor's degree in science or related area (or equivalent)
• 10+ years of experience in clinical data management experience in biotech/ pharma industry; significant hands-on experience in all aspects of data management.
• Experience within all phases of clinical trials.
• Experience with clinical trials and the drug development process
• Significant experience leading data management activities in clinical trials; advanced use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; advanced understanding of DM strategy
• Experience with CDISC (SDTM); as well as data collection requirements in clinical trial
• Experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in clinical trials
• Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices
• Experience working on early and late-stage submissions as per local/regulatory requirements
• Experience working in and leading cross-functional teams

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

$142,500.00---$237,500.00

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 bonuses.

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.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.