Senior Director, Clinical Operations - Operational Excellence and Delivery

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position

Provides strategic vision, expertise, leadership and direction for own function as well as significantly contributing to the strategic planning for Clinical Development Operations (CDO) and the overall CMR function (e.g., provision of trial planning/implementation expertise, health equity initiatives and business development activities). Responsible for the strategic & tactical leadership of the OE function across the USA, including aspects relevant to resource planning (workload/capacity management), health equity initiatives and process improvement initiatives. Responsible for driving innovation to assure that effective risk & mitigation planning occurs in the early planning & ongoing governance of each clinical trial conducted by CDO based on trend reports and other relevant data. Responsible for establishing & growing internal & external partnerships relevant to the continuous improvement of clinical trial planning, placement and governance. Represents CDO and the broader CMR organization at conferences & global meetings.

Relationships

The position is a member of the USO CDO Leadership Team (LT) and reports directly to the Associate Vice President of CDO. The position is responsible for securing and maintaining strong cross functional relationships within CMR/NNI/HQ-GTP, across senior levels of the global Novo Nordisk organization & with senior members from academic, heath care and vendor organizations deployed for CDO. Works with all departments and internal NN stakeholders to ensure multi-disciplinary teams engage in effective strategic and tactical planning for every clinical trial to be considered and/or placed in the USA. Position is expected to be able to build/evolve relationships with leading academic/health professionals and operate as a senior ambassador for NN, our research products and our industry. 

Essential Functions

• Strategic Oversight:
  • Drives clinical strategy development incl strategy for partnerships with key vendors
  • Accountable for strategic alignment of Health Equity initiatives across CMR and NNI to continuously enhance Clinical Trial participant access, diversity, inclusion
  • Provides direction to the OE function as well as CDO/CMR management on matters concerning trial planning, placement, resources,  and site partnerships
  • Represents CDO at internal/external senior forums on strategic/tactical matters related to trial planning, placement & partnerships
  • Accountable for strategy, direction, timelines and effective resource deployment across the function. 
  • Evaluates and communicates the probability and impact of portfolio risks and develops risk management plans for the overall function
  • Responsible for overall functional budget, including expense management and contract management
  • Maintains and builds knowledge of industry trends and developments to innovate and promote future strategic direction for clinical programs, studies, vendors, systems, and sites
  • In partnership with Medical Affairs, supports development of KOL plans and engagements, and leverages KOL input in context of development programs and communicating evidence
• Leadership:
  • Leads teams to assure compliance with policies, procedures, and fundamentals that drive effective trial planning, placement & governance in accordance with applicable laws and guidelines
  • Drives to assure balanced perspectives/progress against strategic priorities of function and negotiates the needs of multiple customers and stakeholders, effectively resolving problems and facilitating escalation as needed
  • Leads local and global senior management team initiatives in relation to improving the w