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VP, Head of CMC Pharmaceutical and Device Development

Ascendis Pharma is seeking a highly motivated leader who has strong experience in the CMC aspects of Pharmaceutical and Device Development including regulatory filings

 

As VP, Head of CMC Pharmaceutical and Device Development at Ascendis Pharma you will be responsible for leading the two departments covering DP development and Device development.

With direct report to the SVP of Product Development, you will be working in very close collaboration with the rest of product development as well as the product supply, quality, regulatory, clinical, commercial and project management teams.

Your main tasks are:

  • Oversee and provide scientific, technical and regulatory guidance for the department
  • Develop DP and device strategies together with the teams
  • Turn strategies into actions
  • Resource allocation and prioritizations
  • Manage our partner collaborations
  • Prioritizing activities and problem-solving to meet milestones and timelines
  • Overall budget according to project plans
  • Update timelines, resources, and budget as timelines and/or strategic priorities shift, and/or issues arise; communicate to all relevant stakeholders (including Senior Management) accordingly
  • Support preparation of materials for internal updates, including Monthly Project Reports, Project Reviews etc.
  • Lead/contribute to operational and process initiatives, as needed
  • Review and contribute to key project documents (e.g., regulatory documents, scientific publications, investor updates)
  • Maintain an up-to-date knowledge on quality and regulatory guidelines
  • Sign master service and quality agreements within are of responsibility
  • Foster excellent cross-functional collaborative spirit and approach

Your qualifications are that you have several years of experience within the field of pharmaceutical and device development. You will have proven leadership skills, preferable of +15 employees, and a proven track record of working cross-functionally. You have good interpersonal skills and demonstrates an excellent understanding and experience of the entire value chain of drug development.

You have a relevant science degree with 10+ years of CMC experience in the biotechnology or pharma industry.

You are a person with a high level of drive, ambition, and passion. You take initiative, are persistent, and pay a high level of attention to details with a goal-oriented approach. You are flexible, pragmatic with an open and communicative approach and with the ability to develop effective working relationships with employees at all levels. You have an interdisciplinary and intercultural mindset.

Ascendis Pharma offers an exciting position with many opportunities in the organisation for professional development and succession both locally and internationally.

Travelling: Availability to travel is required (20%)

Domicile: Ascendis Pharma resides in Tuborg Havn, Hellerup

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant, Anne Thomsen, Unique Human Capital on M: +45 31 40 01 11. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
/ /
cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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