Senior Director - Clinical Operations

About the Department                                                                                                                                               

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

As one of the Directors in Clinical Operations US East Coast Hub you will build, develop and lead an engaged and skilled team of Global Clinical Project Managers and Clinical Trial Administrators responsible for planning and conducting clinical trials within several key assets across our development portfolio. You will become part of the Clinical Operation Leadership team reporting to the Vice President of Clinical Operations, US East Coast Hub.

 

Relationships

Reports directly to the Vice President of Clinical Operations, US East Coast Hub.

 

Essential Functions

• Global coordination of several clinical trials within one or more development programs
• Representing Clinical Operations in Global Project Teams incl. proactive provision of sound operational strategy that will balance operational and data needs while considering innovative approaches to accelerate speed of execution. In this role being accountable for accomplishing the clinical trials within program(s)
• Planning and allocation of the needed resources for a given trial within the clinical program
• Taking a supervisory role and as line manager, ensure competency development and performance management by coaching and guiding your team members, setting expectations, and leading the team to success.
• Lead the implementation of relevant strategies, proactively ensure relevant change management activities, and role model the Novo Nordisk Way.

 

Physical Requirements

20% overnight travel required. Job is based in the USA.

 

Development of People

Supervisory

Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.

 

Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

 

Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

 

Qualifications

• Education: Advanced degree (PhD, MD, PharmD, or equivalent) in a scientific or medical discipline preferred. A bachelor's degree with significant relevant experience may be considered
• Experience: Minimum of 10 years of experience in clinical operations, with at least 5 years in a leadership role within the pharmaceutical, biotechnology, or CRO industry
• Expertise: In-depth understanding of the clinical drug development value chain, clinical trial design, execution, and management, including GCP, ICH guidelines, and regulatory requirements
• Leadership: Proven track record of leadin