Manager, Clinical Operations US

As a Manager, Clinical Operations US you will play a crucial role in establishing Nordberg Medical clinical strategy leading to marketing approval. Additionally, oversight of the complete clinical program for ongoing clinical studies in the US as part of the FDA application process. The manager is expected to be Nordberg Medical ambassador in the US and additional to the above nourish important contacts with KOLs and establish Nordberg Medical as a competitor within the industry.

Key Responsibilities include:

In collaboration with the Clinical Affairs Director ensure:

• CRO oversight
• Regulatory adherence
• Involvement in regulatory discussions
• Ensure scientific integrity of the clinical studies.
• Assist with regulatory and study start-up activities including contract and budget negotiations.
• Ensure clinical data integrity and meet study timelines.
• Complete assigned training programs in drug development processes, therapeutic areas,
• Good Clinical Practices (GCPs) and any applicable local regulatory requirements.
• Establish contact and relationships with key stakeholders within the industry.
• Serve as a subject matter expert regarding US specific requirements.

Required qualifications:

• Experience in medical affairs, scientific communications, or clinical research within the pharmaceutical or medical device industry. Experience working with CROs advantageous.
• MD, PhD, PharmD, or similar advanced degree in a relevant scientific field.
• Strong understanding of drug, medical device development and US regulatory processes.
• Experience from dermatology or aesthetics is highly advantageous.

Personality:

• Proactive, curious, entrepreneurial collaborator, enjoying teamwork - personality traits that strongly align with the company values of Nordberg Medical.
• A can-do-attitude, growth mindset and persistent when faced with challenges.
• Strong stakeholder management skills and the ability to influence across and beyond the organization.

Why should you join our team?

• Growth opportunities: Join our new team in the US and grow with the organization.
• Continuous learning: We provide opportunities for ongoing training and development to support professional growth.
• Entrepreneurial environment: Innovation and creativity fostered by our global and inclusive team.
• Remote-friendly position.