The Role

& Department

As HoF for Programming, the employee will be part of the Development Operations Leadership Team who defines the overall strategy and identify development areas of the organization and ensures that all teams and employees work toward the same objectives and work as one team.

As HoF for the Programming the employee will drive the overall strategy related to programming activities within Genmab in close collaboration with HoF, Biostatistics and HoF, Data Management. The employee is responsible for driving the programming activities across the clinical and regulatory activities related to development programmes/clinical trials and regulatory submissions/filing activities working closely together with relevant stakeholders within CO and across functions.

In addition, the employee will support the development of new therapies by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making. 

The employee will operationally support the Data Management, Statistics, Drug Safety, Medical and Clinical Pharmacology functions across one or more trial and/or programs.

The employee is responsible for establishing standard processes, templates and clinical standards to ensure the quality and timelines of regulatory filings and clinical documentation is in accordance with ICH-GCP and other relevant regulatory guidelines/ requirements.

The employee will drive the oversight of outsourced programming activities not limited to: selection and management of programmers, ensuring that expectations/responsibilities are clearly defined and described in workorders and manuals. The outsourcing activities will be done in close collaboration with HoF Biostatistics and HoF Data Management.

It is expected that the employee act as a role model, proactively engages in department activities, arrange lessons learned to share learnings, leads various initiative, contribute to the overall strategy of the department and proactively contributes to support a global organization.

This position builds strong relationship and close communication/interaction with internal e.g. Data management, biostatistics, regulatory affairs, non-clinical, medical and other functional areas as well as external stakeholders e.g. partners, regulatory authorities etc.

As HoF for the Programming you need to have extensive experience with NDA, MAA, BLA filings, you need to be systematic, organised, proactive, and accountable with good planning and coordination skills. The employee needs to be analytical with the ability to interpret clinical data and other complex information and effectively communicate expectations and information in a clear and concise manner.

As HoF for the Programming the employee may represent Clinical Operations in Project Boards, Global Development Teams and Operational Committee’s/Steering Committee’s with the partners.

As HoF for the Programming group the employee will be responsible for managing, coordinate, develop, supervise and support the employees in the team and ensure that the employees competencies reflect their responsibilities as outlined in their job descriptions.

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 10+ years of people management experience, leading 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:

$,.00---$,.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.