Nykode Therapeutics AS

We are strengthening our Project and Alliance Management team with a Device Associate Director/Senior Project Leader to join us at Nykode Therapeutics! The role will focus on the cross functional project leadership of medical device projects to further leverage Nykode’s technology platform. 

Deadline: 31.07.2022  

Location: Oslo/Copenhagen 

  

About the role 

 

As Device Associate Director/Senior Project Leader you are working across the organization to efficiently lead the planning and execution of medical device projects and coordination with product development projects. Your scientific and technical contribution to the evaluation, planning and execution of projects will be crucial. A significant amount of your time will go to the coordination of scouting and research and development activities with CMOs and consultants. You are driven by producing high-quality and timely deliverables, and have a strong continuous drive to push projects forward together with the project teams. Tracking and reporting on the agreed project plans including timelines, risk management, budget, and resource estimates is something you are experienced with and enjoy.  

 

Other responsibilities of the position include but are not limited to: 

 

• Ensuring that work is performed in accordance with current guidelines and Nykode’s quality management system
• Adapting quickly, managing and handling multiple projects, prioritising work, and meeting deadlines in a timely manner   
• Ability to work in an organized manner, independently by taking initiative to troubleshoot problems and pursue resolutions  

• Leading, motivating and inspiring teams to excel in a high-performance culture and cooperating with multiple stakeholders and functions in cross-functional teamwork   
   
   

Education and experience 

 

• 5+ years’ experience with medical device development and project management within an R&D organisation  
• Relevant academic degree within engineering or pharmaceutical sciences with specialty in medical device development, mechanical or production engineering or similar

• Documented experience with medical device and/or combination product development and preferably regulatory approval from the pharmaceutical and/or medical device industry  
• Experience with SC, IM, TD delivery devices (e.g. needle free, jet, electroporation, microneedles)  
• Solid understanding of the Medical Device Regulations in EU and US and regulatory pathways, ISO13485 knowledge, MDR article 117, 21CFR Part 4
• Knowledge of Design Control and Risk Management for MDs 
• Experience with vaccines and e.g., immuno-oncology is an advantage  

  

Who are we looking for? 

 

When hiring new employees, we look for people who are inspired by Nykode's technology and our quest to unlock the future of medicine. We embrace new ways of thinking and doing. When growing and building our teams, we look for people inspired by our mission and those seeking to join a collaborative and value-based company culture. An eagerness to learn and continuously develop is a core characteristic of our highly skilled and competent individuals. Life at Nykode is an opportunity to take part in the journey to push the boundaries of human advancement. Our work is meaningful, and we care. We care about the patients, and we care about each other. 

 

Your eager to proactively contribute to the Nykode team by ensuring that our culture is aligned with people´s values. You foster a work environment where people thrive at work and actively take part in strengthening the project organisation.  

  

The application process 

  

Applications will be reviewed on a rolling basis. We are looking forward to receiving your application! We do not accept applications by mail. Should you have any further questions regarding the position, please reach out to us: recruitment@nykode.com