Director – Submission Standards & Implementation

Role Overview

• 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
• 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

Requirements

• 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.

Benefits

• Health insurance
• Professional development opportunities