Vice President - Clinical Operations

About the Department

The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference? 

 

The Position

The Vice President, of Clinical Operations will provide leadership of Clinical Operations and Clinical Documentation colleagues based at our newly formed Boston Global Development site in Lexington/Boston, MA, USA. The VP of Clinical Operations will lead a team of professionals to ensure strategic and operational execution of the drug development pipeline with a focus on life changing medicines based on our siRNA technology platform and other advanced technologies. The VP of Clinical Operations will work globally in a matrix organization on the planning and integration of all Clinical Operations activities.

 

Relationships

This role reports to the Corporate Vice President, Head of Boston Global Development.

 

Establishes and manages senior level relationships with multiple internal stakeholders relevant to the design and implementation of clinical trials and improvement/innovation projects for Novo Nordisk, including but not limited to: Members of the VPForum, Project Management (PVPs), Novo Nordisk Regions/CDCs/Business Areas/Affiliates, Medical & Science, Data Science, Strategic Development (GTP, GDOM & Business analysts), R&D Quality, Clinical Supplies, Global Safety and Submission & Lifecycle Management.

 

Establishes and manages mutually beneficial relationships with external partners relevant to the design and implementation of clinical trials and innovation/improvement projects for Novo Nordisk, including but not limited to: Investigators, Suppliers and third parties, Health authorities/IRB/EC and Cross-industry partnerships such as Trans-Celerate and others.

 

Essential Functions

• Achieves clinical project success by ensuring operational strategy and planning
• Sets ambitious and visionary targets for the Clinical Operations area
• Sets clear expectations and appropriate guidance on ‘what good looks like’ for the Clinical Operations roles to drive transformation within clinical drug development in HQ and across the global organization through the CMRs
• In collaboration with other Clinical Operations VPs proactively leads the optimization of processes and drives the architecture and future operating model for Clinical Operations
• Is accountable for driving an engaging culture in accordance with Novo Nordisk Way and for inspiring and motivating employees and teams through empowerment and by enabling judgement-based decision and agility
• Leads the Clinical Operations Management team and ensures corporate Line of Business activities e.g., resource planning, training and development, Health and Safety, Workplace Assessment etc.
• Is overall accountable for ensuring optimal resource utilization within the area/development portfolio at all times
• Is responsible for providing feedback regarding resource constraints and progress on defined deliverables to relevant stakeholders
• Drives talent and succession management, identifying high potentials and creates an environment where a learning culture is in focus to support individual and organizational learnings and development
• Is overall responsible for the Clinical Operations LoB budget
• Contributes actively to the Organizational Development Plan (ODP)
• Is responsible for assuring compliance with the Novo Nordisk Quality system for Clinical Operations deliverables
• Is a member of the CPVP Leadership Team, including actively contributing to the leadership and future development of the area
• Is a member of the Global Trial Management Council (GTMCouncil) and the Head Quarter Trial Management Council (HQTMCouncil)
• Is sponsor/StC member of Clinical Drug Deve