Project Manager (NL)

 

Your job in a nutshell

As Project Manager you will be dedicated to a project or more projects that cover the full range of in-vitro diagnostic assay development process from marker discovery, development, and validation until market authorization such as approval by appropriate regulatory authorities, and may include post-market introduction activities such as label claim extensions, life cycle management. The Project Manager is responsible for the coordination of the development of the assays according to high quality standards in a timely manner, as well as the management of internal and external collaborations required within the projects.

 

The Project Manager liaises with clinical investigators in coordination with business unit Scientific & Clinical Development and Commercial Development in order to acquire user input and host scientific advisory board meetings for the development of the products as well as the commercialization thereof. Project planning and budgeting are job objectives. The Project Manager is also responsible for defining and assigning the roles and responsibilities of the different project team members, in agreement with the applicable SOPs and SkylineDx’ organizational structure and the direct department manage. You will report to the President, General Manager USA.

 

Together we ensure the validation and implementation of clinically relevant scientific discoveries into reliable medical diagnostic assays for diagnosis, prognosis and drug effectiveness prediction that will ultimately contribute to improved patient care.  

 

You have

  • a Master’s degree or PhD in a relevant area.

  • 2 - 5 years of experience in project management (preferred).

  • worked under GMP standards and ISO 13485 requirements.

  • experience with the EU IVD directive 98/79/EC, EU Regulation 2017/746, the US medical device regulations, ISO 13485, ISO 15189 and the 21CFR820 Quality Management system standards.

  • experience with translating state-of-the-art science into products that matter to patients.

  • experience in molecular techniques such as PCR, microarray or NGS technology.

  • knowledge of molecular diagnostics, genomics, assay validation, statistics.

  • strong analytical skills and creative approach to problem solving.

  • an entrepreneurial mind-set and are able to work in an environment with high quality standards.

  • an excellent command in written and spoken English.

  • the ability to motivate the team and manage both internal and external collaborations.

  • a hands-on mentality and result oriented attitude.

  • affinitive with our corporate quotes/ values (must).

 

We offer

  • a full-time position, a market competitive salary and market competitive secondary conditions of employment.

  • opportunities for personal growth.

  • the best of two worlds: a career in life sciences at an innovative biotech company with the emphasis on clinical diagnostics in close collaboration with an academic environment.

  • the ability to serve society with science based solutions.

 

At SkylineDx

we live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission. And when needed our passionate side surfaces to clear the way so we can serve society with science based solutions.

 

Our quotes

#serviceisjoy

#valueformoney

#playtogethertowin

#amazingthingshappen

#cogitoergosum

#itsyourparty

 

Do apply!

Send your resume and motivation letter to Soraya Mestar (HR) at hr@skylinedx.com. If you have questions or want more information, don’t hesitate to contact us. You’ll find the contact details here on our website. We will make sure it lands on the right desk!