Vp, Clinical Development, Medical, Regulatory
2 weeks ago
**Working at Novo Nordisk**
At Novo Nordisk, your skills, dedication and ambitions help us change lives for the better for 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. In exchange, we offer you an opportunity to work with extraordinary talents and benefit from a range of possibilities for professional and personal development.
**Summary**
The Vice President, Clinical Development, Medical & Regulatory (CDMR) provides overall leadership and management of the Medical Affairs, Regulatory and Clinical Development functions with the goal of maximizing the life cycle of Novo Nordisk products and pipeline projects: before, during, and after launch.
**Major Accountabilities**
Leadership
- Provides general direction for the development, implementation and coordination of clinical development, medical affairs and regulatory plans
- Provides general direction to CDMR Management related to departmental goals and priorities.
- Fosters cross-functional collaboration and facilitates communication within, and outside of CDMR. Provide expert level support and guidance cross-functionally on issues related to CDMR functions, as appropriate
- Manages the employees of the department, interviewing and hiring new employees, carrying out performance appraisals, directing the training and development of staff and carrying out disciplinary actions in coordination with CDMR Management Team
- Maintains and champions quality mindset in all business processes within CDMR, and coordinates process improvement initiatives
- Ensures full compliance to Novo Nordisk Quality system, Business Ethics and all other applicable rules and regulations
- Creates and maintains a positive work environment where all employees can maximize their job satisfaction, potential and productivity
- Be a promoter and incubator of talents for CDMR.
Executive Management
- Acts as a member of the Executive Team developing, recommending and implementing strategies, and action plans to achieve the goals of the company
- Participates in cross-functional teams, as appropriate, developing, recommending and implementing short and long-term strategic goals for the company
- Develops and manages departmental budget, monitoring progress throughout the year, reviewing and revising as appropriate
- Liaises with other Executive Team members and parent company management staff to communicate information, resolve problems and identify corporate priorities
- Participates in the general management of the company, attending Executive Team meetings and making strategic and policy decisions
Department Management
- Directs the provision of technical training and information regarding medical and scientific issues to field sales and head office employees
- Directs the provision of timely, relevant and accurate medical and product information to all classes of customers
- Provide medical input to marketing plans, promotional campaigns, and new product launch platforms including the provision of medical input to the Brand Teams, product launch teams, LCM activities or other relevant bodies
- Ensures that marketing materials and programs have been reviewed for medical content, regulatory requirements and ethical standards
- Provides overall guidance and strategic input on the Medical Education activities and scientific educational efforts in support of sponsored scientific events and learning programs as appropriate
- Maintains regular and frequent contact with key opinion leaders (KOLs) in diabetes, Obesity, and other relevant therapeutic areas. Ensure strategic plans in place for engaging and appropriately communicating with the top national and global KOLs
- Direct collaboration between Canadian staff and counterparts within the Region and Global organizations
- Provides strategic input to Canadian clinical programs from initial concept to finalization
- Enhances the product development process by cross-functional support of the development and implementation of market access programs and services, including pharmacoeconomics, outcomes research and disease state management programs
- Provide strategic oversight to the process of internal submissions and evaluation of investigator-sponsored studies (ISS) in collaboration with key stakeholders within NN Canada and globally
- Directs all product and service development process by ensuring the relevant reviews of clinical summaries and reports for medical content in support of submissions to Health Canada
- Directs the regulatory approval process to meet or exceed industry standards
- Maintains current knowledge or regulatory environment
- Strategically supports the communication and dialogue with Health Canada in relation to the Canadian regulatory process and other relevant engagements
- Maintains up-to-date knowledge of functional area, health care industry and general management issues
- Assesses and maintains medico-legal and ethi
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