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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Chief Technology Officer (CTO)


Reference:SCAIMI-567665 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Chief Technology Officer (CTO)
Our client, a biotech organisation establishing operations in Ireland, are currently recruiting for a Chief Technology Officer to join their business. The main task of the CTO is to lead the device development part of the drug-device combination product. The CTO is involved in the strategy and operationalization of the technical development and regulatory strategy.


Responsibilities

  • Related to device development, coordinates input from external regulatory affairs consultants and identifies and closes knowledge gaps
  • Lead device-related activities towards the U.S. FDA and EMA
  • Lead the development of the device regulatory timelines, resources, budget, risk, and quality plans
  • Accountable for meeting or exceeding goals for device develop projects
  • Ensures the maintenance, tracking, and accuracy of regulatory data and milestones
  • Develop and maintain effective working relationships with Executive Management, other R&D Management and CMC Project Team members
  • Own the regulatory documents related to device development as well as the Investigational Medical Device Dossier (IMDD), as appropriate
  • Develop or provide device-related input to the development of CMC, non-clinical and clinical study documents, including study protocols and reports, IMPD, and Investigator’s Brochure
  • Keep up to date with local and international regulatory requirements. Specific focus on device-related requirements
  • Regularly communicate the regulatory and development activity status and timelines and escalates unresolved issues appropriately
  • Lead responses to device-related study questions or issues from Health Authorities or EC/IRBs, including adaptation of procedures towards the new EU CT Directive and Medical Device Regulation (MDR), as implemented.
Requirements
  • University Degree related to engineering or Life Sciences (e.g., engineer, human biology, biochemistry, biology, pharmaceutical science, chemistry).
  • Proven device development experience in a consultancy, pharmaceutical and/or biotech company of at least 10 years,
  • Experience with inhalation devices is required
  • Document owner of full or parts of the regulatory dossier
  • Ethics Committee and Competent Authority submissions
  • Development of timelines, budgets and resource plans in complete and/or partially outsourced settings
  • Experience of leading/overseeing external vendors (device development consultants and CDMOs)
  • Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines
  • Updated knowledge of ICH GxP requirements
  • Experience with regulatory support of development of scheduled drugs is a benefit
  • Experience with IND, NDA submissions in the U.S. and CTA/MAA submissions in Europe is a benefit
  • Self-driven and motivated team player
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Excellent written and verbal interpersonal communication, influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
  • Good organization and tracking skills, as well as attention to detail
  • Mandatory fluent English (both oral and written) – other languages are an asset