Director - Submission Standards & Implementation

Are you an experienced People Leader looking for an opportunity to lead a leader and a team?

Do you have talent for leading and developing others?

Do you have experience with SDTM, regulatory submission standards, statistical programming or data management?

Do you enjoy developing people and processes at the same time?

If so, you could be Director of Submission Standards & Implementation. Apply today!

About the Department

In Research & Development, we manage clinical drug development worldwide, ensuring that the process lives up to uniform global standards, regulations and business ethics while delivering viable products that make a difference to patients and ultimately benefit society.

Our department, Submission Standards & Implementation, delivers its responsibilities through a team of enthusiastic and highly engaged people. Our responsibilities are to:

• Develop and drive strategy for the SDTM (CDISC Study Data Tabulation Model) data standard development at Novo Nordisk, clinical dataflow and regulatory submissions across R&D
• Partner closely with internal and external stakeholders to ensure high-quality, compliant data submissions and to implement standardised, scalable solutions across in‑sourced and outsourced trials.
• Oversee SDTM generation engine development and maintenance as well as supporting other system and dataflow improvement projects
• Collaborate with internal and global organisations in developing SDTM strategy, standard processes and enterprise data infrastructures that deliver to business outcomes at optimal efficiency

As Director – Submission Standards & Implementation within the Data Standards and Integration (DSI) area of Clinical Data Management & Programming (CDMP), you will be overall responsible for the deliveries of the department. You will report to the leader of DSI and be part of the cross-geographic leadership team. To succeed in the role, you must therefore have strong leadership and stakeholder management competencies and an international mindset as you will be working across geographies and cultures.

Your primary responsibilities include:

• Accountability for the department responsibilities as detailed in the bullets above including overall responsibility for the SDTM generation strategy, consistency and toolsets as well as system ownership of acquired company dataflow systems
• Managing the overall operational, budgetary, and financial responsibilities and activities of the department
• Staying curious, empathetic, listening to understand, and support the team through the department’s diverse and fast-paced project commitments
• Supporting collaborators, peers and the team with sparring and support with handling delivery or execution challenges
• Developing and driving people strategy, including sourcing of talents as well as recruitment, retainment, attraction, and rotation
• Ensuring team engagement and capabilities development within your team to deliver to efficient operations, business transformations as well as large strategic initiatives
• Representing the area in one or more internal or external governance fora
• Establishing and sustaining excellent close-knit stakeholder relationships across the value chain your team delivers to
• Identifying, participating and driving business improvements

The team waiting for you

In Research & Development, we manage clinical drug development worldwide, ensuring that the process lives up to uniform global standards, regulations and business ethics while delivering viable products that make a difference to patients and ultimately benefit society.

The department, Submission Standards & Implementation, delivers its responsibilities through 15-20 enthusiastic and highly engaged people working alongside a manager to support with the leadership of the team and managing deliverables.

What you bring

We see our next colleague as having: 

• An advanced degree (Master’s or PhD) in Data Science, Computer Science, Life Sciences, Engineering or a related field
• Proven track record of people leadership; ability to motivate others to advance goals, and the ability to effectively manage multiple projects or roles in a rapidly evolving environment
• 10+ years of relevant experience in Data Management, SDTM, Clinical Programming, Regulatory Submissions or Statistical Programming within the pharmaceutical or biotechnology industry is preferred
• Experience working with complex projects driven by strategically crucial timelines along with strong stakeholder management and communication skills
• Curious and empathetic towards the team and stakeholders and experience working in a matrix and cross-geographic organization preferred

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energies us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

For further information, please contact Rhona O’Donnell (rnoe@novnordisk.com)

Application Deadline: 17th April 2026. Please notice applications will be processed as they are received.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.