Senior Director, Head of Programming
4 weeks ago
The Role
As the Senior Director, Head of Programming at Genmab, you will be part of the Development Operations Leadership Team who defines the overall strategy and identifies development areas of the organization. You will ensure that all teams and employees work toward the same objectives and work as one team.
As the Head of Programming, you will drive the overall strategy related to programming activities within Genmab in close collaboration with other departments. You are responsible for driving the programming activities across clinical and regulatory activities related to development programmes/clinical trials and regulatory submissions/filing activities working closely together with relevant stakeholders.
Key Responsibilities:
- Drive process development and standards within programming where continuous improvements are 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, supervising, and developing 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 represents 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
Requirements:
- 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, takes responsibility, and shows initiative
- Excellent communication skills
- Excellent planning and coordinating skills
- Ability to flexibly work on multiple tasks without compromise of the quality of the work
About Genmab:
Genmab is a biotechnology company that leverages the effectiveness of an agile working environment 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.
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