Director, Clinical Data Manage

At Genmab we are dedicated to building extranotordinary 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!

The Director 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 conjunction with the Senior Director DM the Director DM contributes to and supports the strategic direction of the Clinical Data Management functional area and ensures activities and processes support the efficient and effective execution of clinical trials. They support the development of standards provide system oversight support and support digital security strategies as well as drive/support audit/inspection readiness activities. Furthermore it is expected that the employee will lead/support and facilitate process optimizations and process development within the department and within Clinical Operations in alignment with ICH-GCP and relevant guidelines. This includes but is not limited to writing and contributing to Genmab SOPs procedures and guidelines within Clinical Operations and across functional areas.

The Director DM will also be responsible for activities related to outsourcing of DM activities. They will ensure establishment of relevant processes to ensure oversight of data management vendor partners to empower high quality standards and performance. The Director is expected to work in close collaboration with other functional areas within Development Operations and Clinical Development to support cohesive end to end DM processes across vendors.

The employees will be part of one or more Partnership Operational Committees with vendors and be responsible for review and establishment of state-of-the-art DM process improvements to build efficiencies and improve data quality of data management deliverables.

The employee will be part of the extended DM leadership team and which supports the overall strategy for the department defines the overall operational strategy unified objectives and areas for development of Clinical Operations.

It is expected that the Director DM drive work order review activities within the data management area and support program budget oversight activities.

Furthermore the Director DM may be responsible for leading managing and developing employees in Clinical Data Management and to ensure that the employees competencies reflect their responsibilities as outlined in their job descriptions. Through empowerment they will utilize the full potential of their employees and ensure employees are held accountable for their deliverables.

On the more personal level it is important that you challenge and improve current processes and support new working methods and working styles.

Requirements:

• Bachelors degree in science or related area (or equivalent); Masters 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 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 with CDISC (SDTM) as well as data collection requirements in
• oncology trials
• Experience in budget management
• Direct experience with EMA FDA and PMDA inspections preferred

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

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 youre 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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs 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.