Vice President - Clinical, Medical and Regulatory Strategic Operations

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

The Vice President (VP), Clinical, Medical and Regulatory (CMR) Strategic Operations is responsible for managing and overseeing Product Safety and Pharmacovigilance, GxP Support incl. Quality Assurance and quality management systems, Strategic resource management and the functions responsible for CMR wide future planning and readiness. The responsibilities included in readiness and planning are Business development assessment, asset integration, early pipeline development and centralized knowledge management and onboarding.

Relationships

This position reports to the Senior Vice President, CMR and is a member of the CMR LT. Internally, the VP interacts with ET members and critical senior personnel within Novo Nordisk Inc. (NNI), NN A/S, as well as other Novo Nordisk (NN) affiliates. Externally, interactions include: Regulatory Authorities, KOLs, advisory board members, investigators, personnel in other companies regarding asset evaluation and discussion, vendors, and colleagues in relevant professional associations.

Essential Functions

• Develop short and long term strategic plans for Strategic Operations and ensure execution through organizational relationships and team leadership
• Working with other leadership team members, accountable for CMR operational readiness and ability to perform in the future
• Develops and implements Strategic Operations policies and objectives. Reviews, assesses, and revises procedures and SOPs to improve efficiency, workflow, and implementation
• Lead and manage a diverse group of professionals with varied functional expertise to mold an effective team and expand its capabilities. Build a collaborative team environment that holds everyone mutually accountable for overall success
• Ensures that electronic document issues are identified and addressed for medical/technical documents and that staff remain current with developments in project areas and changes in regulatory requirements and project needs
• Liaison with HQ, professional societies, and NNI/NNAS colleagues to share and implement best practices within the Department
• Ensures development and execution of strategy for all pharmacovigilance activities within NAO (NNI and NNCI).  Ensures adherence to the processes, procedures and controls to meet internal SOP, US and Health Canada Regulations relating to technical complaints, adverse events and other safety information
• Oversees the direction and development of SOPs at NNI and NNCI documenting compliance with corporate policies and local safety needs, as well as ensuring a global safety platform is established for managing work load and better practice sharing
• Responsible for ensuring the compliance with FDA and Health Canada AE and MDR safety reporting and regulations and ensures FDA and Health Canada safety submissions as requested
• Oversees the Quality support for all U.S. based manufacturing facilities, product warehouses and Supply Chain to enable release of product to the US market according to business needs
• Leads the GxP support team to develop and implements an effective and compliant quality management system (QMS) across NAO. Responsible for setting strategy for the function, aligned with global expectations & partnerships. Provides direction to GxP support function as well as NAO management on matters concerning Product Quality, GCP compliance and vendor management/vendor audits
• Responsible for the conduct and communication with the FDA and Health Canada inspectors during site and sponsor-related inspections in the USA and Canada and serves as the Novo Nordisk point of contact for global sponsor inspections by any health authority
• Ensures robust business operations support to CMR including business planning, strategic resourcing management and budget
• Oversees NAO CMR input to BD asset evaluation and readiness for early pipeline (e.g., cell & Gene therapy). Responsible for organizational readiness for and execution of successful integration of newly acquired assets and companies into operation across CMR in North America
• Builds pan-CMR training programs focused on building capabilities to drive growth. Deliver Pan-CMR onboarding program to drive consistent employee experiences and instill Novo Nordisk Way culture
• Provides subordinates with the opportunity to lead to motivate them to advance in their careers; Coach, mentor, and develop them in order to enhance both current capabilities and to build the skills and talent necessary for the future

Physical Requirements

20-30% overnight travel required.

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

• A Bachelors degree required, MD or other advanced degree preferred in a health related arena .  
• Minimum of 15 years of experience in strategy and/or operations, with a focus on areas such as Quality, Pharmacovigilance, Clinical Trials Operations, Medical Affairs, or Regulatory Affairs preferred
• Prior pharma industry experience required
• Minimum of 5 years’ experience in a senior leadership role
• 10+ years of supervisory experience demonstrating extensive strategic planning for a business of a large sized team, and proven ability to engage, manage, develop and inspire a large team
• Ability to execute and solve highly complex problems and make bold decisions even when facing ambiguity or in the absence of complete information
• Demonstrated knowledge and experience with Drug Safety Reporting and FDA guidelines regarding Adverse Events (AEs) and MDRs
• Demonstrated knowledge and understanding of statistical methods, regulatory requirements, and clinical development processes
• Demonstrated knowledge and experience with Quality Assurance processes and activities
• International experience, preferably dealing with European authorities and/or HQ preferred
• Proven ability and flexibility in the management of simultaneous priorities, changing deadlines, and limited resources
• Proven experience in business operation including business planning, resourcing management and budget etc. M&A experience is preferred
• Ability to develop strong working relationships with key stakeholders within NN both locally/globally and external stakeholders (vendors, industry thought leaders) and represent NNI

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.