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Director, Device Development

In a fast growing Biotech company

Ascendis Pharma, a visionary and ambitious company, offers you a once-in-a-lifetime opportunity to become a key participant in the further establishment of the structure and function of device development, with a unique influence on shaping the way devices are developed in the future.

As Director, Device Development at Ascendis Pharma, you will be responsible for managing the device activities in new drug/device projects with partners and contract manufacturing organizations. You will report to the VP, CMC Pharmaceutical and Device Development. There are currently no direct reports to the position, but Ascendis is growing rapidly and this may be changed in the future.

Your key responsibilities:

  • Provide input to and take ownership of design and development of the medical devices used for Ascendis Pharma’s combination products including mentorship
  • Coordinate and manage medical device CMOs
  • Prepare system engineering and risk management documentation for combination products and medical device systems
  • Ensure that all activities are conducted in compliance with relevant regulatory requirements
  • Mature quality system for medical device documentation generated during development from concept to commercial readiness and transfer to Product Supply
  • Ensure that the medical device part of pharmaceutical development and manufacturing processes are conducted optimally with respect to quality, timelines and budget.
  • Responsible for outlining medical device agreements and work orders for specific tasks together with the legal staff
  • Involvement in writing and reviewing regulatory documentation for the medical device part of INDs/IMPDs, NDA/BLA/MAAs
  • Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources
  • Support inter-departmental communication and ensure effective handovers to execute on important project milestones
  • Report on project progress via monthly status reports

You hold a relevant Master’s Degree combined with +10 years of experience from working with device development and project management, preferably with injection devices/combination products.

Qualifications required for the position include industry experience with planning and executing medical device development projects including user driven development based on usability studies. In addition, you have a proven history of effectively contributing to business plans at both the tactical and strategic levels.

Furthermore, you have a solid background and experience in working with external partners (CROs, CMOs and consultants) and you have extensive knowledge of world-wide medical device regulations  as well as other international regulatory guidelines. You are knowledgeable about drug regulations, have experience from working in projects involving both drugs and devices, and you are comfortable managing multiple programs with competing and aggressive timelines. Finally, you can prioritize activities and work independently in rapidly changing internal and external environments.

You have excellent English communication skills, both written and spoken and you are an advanced user of MS Office, and other relevant IT tools or systems. 

As a person you have a high level of drive, ambition, and passion. You take initiative, are persistent,  pay attention to details and you are goal-oriented. You are comfortable with a risk-based approach to decision-making in a dynamic environment in which priorities and drivers can change rapidly. You can communicate clearly towards upper management and you are an active project player who cooperates closely with other departments at Ascendis Pharma. Finally, you are quality driven, open-minded, robust, able to stand firm, and you like to have fun. 

At Ascendis Pharma you will be part of a stimulating and informal innovative working environment interacting with both colleagues and partners to deliver on Ascendis’ ambitious corporate goals.

Travelling: Approx. 20 – 30 days a year

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbour, the canals and the sea.

For more details about the job or the company, please contact please contact Unique Human Capital, Research Consultant, Jeanne Dederding on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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