Job Description

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Sr. Director, Clinical, Medical and Regulatory (BASEA)

Category: Clinical Development and Medical

Location:

Singapore, Singapore, SG

Are you seeking a dynamic work environment where your expertise can make a significant impact? Are you ready to aid the business in a region with one of the biggest growth potentials? Look no further! We are currently seeking a Senior Director, Clinical, Medical, Regulatory & Pharmacovigilance to join our organization and become a strategic partner to the business in our South-East Asia operations. Apply now!

About the department

Novo Nordisk is a global healthcare company with 100 years of innovation and supervision in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders, rare diseases, and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 60,000 people in 80 countries and markets its products in more than 170 countries. Business Area South-East Asia (BASEA) comprises of Malaysia, Singapore & Brunei, Vietnam, Bangladesh, Philippines, Sri Lanka & Maldives and Laos, Cambodia & Myanmar. BASEA is part of the APAC/International Operation Unit (IO).

The position
Your primary duty is to manage all related Clinical, Medical, Regulatory and Pharmacovigilance aspects of Novo Nordisk business including a specific focus on Research and Development (R&D) pipelines within the Business area Southeast Asia (BASEA). This position will report to the Corporate Vice President, BASEA and it will be based in Singapore. You will have 6 direct reports in BASEA and functional reporting of affiliate - Clinical Medical Regulatory (CMR) Heads.

The main scope of accountabilities includes but is not limited to:

• Head Clinical Medical Regulatory (CMR) strategy (short, mid, and long term) and performance management in alignment within BASEA. Drive for Best practice and operational excellence. Communication and interaction with both internal and external stakeholders.
• Clinical operations - Oversee Clinical activities in BASEA and endorsement of local trials as well as explore new opportunities/countries.
• Medical Affairs - take care of therapeutic areas in Business Area, BASEA as well as aid and drive medical projects.
• Regulatory Affairs - Strategize, initiate, plan and coordinate with necessary departments including corporate regulatory affairs, trademark for regulatory submission, approval, and maintenance of licenses. Ensure the units are in compliance with Regulatory and Pharmacovigilance requirements.
• Pharmacovigilance - Ensure Novo Nordisk safety standards are followed. To ensure the units within BASEA operates in compliance with Regulatory and Pharmacovigilance requirements and ensure discussions with General Manager (GMs)/ Multiple Country Manager (CMs) with BASEA to allocate resources and provide means that allow employees to fulfil their duty Work according to the company values, the business ethics, and internal laws.

Qualifications

• Minimum of 12 years experience with 8 years of people management in senior roles in the pharmaceutical industry. Experience in randomized controlled trials (RCTs), real-world evidence (RWE) - Observational studies, Prospective studies.
• Medical Doctor with MD is mandatory.
• Global R&D experience is required in conducting multinational clinical trials. Global knowledge of Medical Affairs and requirements for Regional Medical Affairs.
• Experience in engaging with Regulatory bodies and drug safety. Experience in translating clinical evidence into strategies for successful product development and launch preparation.
• Have excellent managerial skills, strong matrix and influencing skills.

Working at Novo Nordisk

At Novo Nordisk, we don\'t wait for change. We drive it. We\'re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales - we\'re all working to move the needle on patient care.

Contact

Upload your CV to our online career page (click on Apply and follow the instructions).

Deadline
4 Oct 2023

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