Senior Director, Head of Programming

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department

As Head of Function for the Trial Management team, you will be part of the Trial Strategy and Delivery Leadership Team (TSD LT) who defines the overall strategy and identify development areas of Trial Strategy and Delivery (TSD) and ensures that all teams and employees work toward the same objectives and work as one team.

This role will be responsible for managing, coordinating, supervising, and supporting the employees in the team and ensuring that the employees’ competencies reflect their responsibilities as outlined in their job descriptions.

In addition, this role must drive update/development of processes in Trial Strategy and Delivery (TSD) with specific focus on trial management activities and ensure these are scalable and up to date with relevant guidelines and regulations and aligned with the relevant vendors, e.g., Clinical CROs.

Moreover, this role shall support the overall strategy and development of Trial Strategy and Delivery (TSD) by attending/leading task force initiatives within the department and/or as part of cross-departmental teams.

It is the responsibility of this role to ensure that the employees have adequate scientific and operational knowledge and work in accordance with ICH-GCP, internal SOPs and guidelines.

This role will represent the department in several cross functional working groups/project related activities or leadership meetings/forums.

Key Responsibilities:

The tasks and department responsibilities are a non­exclusive list of high-level tasks:

• Drive process development and standards within programming where continuous improvements is in focus
• Drive resource planning and outsourcing of programming activities
• Prepare and participate in audits and inspections
• Participate in due diligence activities, if applicable
• Drive scientific forums/workshops/learnings, as applicable
• Lead/contribute with knowledge sharing within the Clinical Operations
• Lead and participate in cross-functional working groups/projects/task forces
• Contributes to ongoing improvements and lessons learned in cross-functional and global collaboration and sharing of better practices and knowledge

• Overall responsible for managing, supervise and developing of people in the Programming Team
• Support developing of people
• Development of training plans, ongoing training and JD for employees within own functional areas and ensuring employees
• Keep own and employees dossier up to date and that employees within own functional areas are compliant (timely R&U of SOP, are sufficiently trained etc.).
• Support the expansion of Development Operations in DK, NL, Japan and US and support development of people globally
• Responsible for hiring of new employees within Programming in close collaboration with relevant stakeholders
• Proactively contributes to support a global organization
• Maintains up-to-date knowledge and competencies within relevant therapeutic, regulatory guidelines/requirements and ensure it is reflected in Genmab programming processes and standards
• Participates and represent programming in teams and meetings
• Further build a framework for the department focusing on the growth, developing new and “innovative” ways to work with internal and external partners in a global context utilizing an outsourced model
• Drive or support various change initiatives
• Keep overview of consultancy contract and costs within own area
• Accountable for budgeting of activities related to programming

Other activities:

• The employee may also support senior management on own or partnered.
• The Employee shall render such other related services and duties as may be assigned to him/her from time to time by his/her supervisor.

As Senior Director, Head of Programming, it is expected that the employee:

• Acts as a role model
• Proactively engages in department activities
• Arranges lessons learned to share learnings
• Leads various initiatives within the department
• Proactively contributes to support a global organization
• Acts as mentor for new employees or consultants

Requirements - what you must have

• Bachelor’s degree required or equivalent (e.g., number of years of experience and/or skills)

• Minimum of 15+ years of experience in clinical trial management and 5+ years of people management experience, leading large-sized, highly competent, and dedicated team(s).

Competences:

• SAS programming or similar languages such as R, Python, etc.

• Analytical and problem-solving skills
• Knowledge of the CDISC SDTM and ADaM data models: the corresponding structures and organizations of the data.
• Contextual understanding of the data
• Writes efficient, easily maintained and well documented computer programs
• Is systematic and organized in writing and archiving computer programs
• Thorough
• Proactive and Accountable and Goal oriented
• Innovative
• Good team player
• Expert at sharing knowledge
• Works independently, take responsibility and show initiative
• Excellent communication skills
• Excellent planning and coordinating skills
• Ability to flexibly work on multiple tasks without compromise of the quality of the work

Where you will work

This role can be based in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, the Netherlands and is hybrid.

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

$206,250.00---$343,750.00

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 .

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 https://www.genmab.com/privacy .

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.