Senior Manager - Operational Excellence & Delivery Trial Planning (remote)

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 health-care-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

Responsible for designing, developing, and delivering analysis to support successful clinical trials particularly in the areas of patient allocation, feasibility, site identification, and risk evaluation within North America Clinical Development (NACD).

Provides high-impact reporting leveraging technology-driven data guiding decision making toward business objectives. Provides tactical cross-functional leadership to staff within NACD.

 

Relationships

Reports to Associate Director (or above) in the OED function within NACD.

Manages mutually beneficial external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g., Health Systems, Contract Research Organizations, Clinical Vendors, and Site Management Organizations, etc.).

Secure strong relationships with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), HQ CDD & Commercial).

 

Essential Functions

• Planning and Strategy: Develop study-specific strategic plans to achieve organizational goals, based on data analysis and predictive modeling, ensuring alignment with overall business objectives thru cross-functional project and stakeholder management; Study-specific strategy includes development of investigator & site profiles, requirements, and ranking; Align on project strategy with OED and Portfolio Director
• Solutions Oriented: Proven ability to proactively identify opportunities/risks and partners with internal and external stakeholders and team members to develop, plan, and execute on the opportunity or mitigation
• Process Improvement: Identifying areas for improvement in trial planning processes and implementing changes to enhance efficiency, productivity, and quality; Could include leading optimization initiatives for development and implementation
• Onboarding and Training:  Provides coaching/mentoring/training to peers
• Risk Management: Assessing and mitigating risks associated with trial planning; high degree of adaption and scenario planning requiring strong change management skills
• Cross-TA Collaboration: Working closely within OED function as well as other departments to coordinate trial planning activities, facilitate communication, and foster a collaborative work culture
• Continuous Improvement: Encouraging a culture of continuous improvement, promoting innovation, and seeking ways to optimize trial planning through new technologies or practices; Contributes to local and global team initiatives
• Stakeholder Management: High degree of independent interaction engaging with internal and external stakeholders, such as customers, suppliers, and partners, to build relationships, address concerns, and ensure effective and efficient trial planning

 

Physical Requirements

10-20% overnight travel required. May require occasional work outside of standard business hours to support special requests/events. The incumbent can work remotely from anywhere in the United States. 

 

Qualifications

• A bachelor’s degree is required.  An advanced degree in a science related discipline is preferred
• A minimum of 8 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting required
• Prior supervisory, project management or leadership experience preferred; A minimum of 3 years previous early trial planning experience (site feasibility, site identification, recruitment planning) preferred
• Knowledge of ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical trials preferred
• Works independently; receives minimal guidance
• Strong communication skills (verbal, written, presentation) in Englis