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Associate Director/Director, Device Development

Reference Number: 2942
Location: East Coast

Our client is a leading pharmaceutical company.  They have asked us to assist them in their search for an Associate Director/Director, Device Development.

This position can be filled at either the Associate Director or Director level depending upon experience.

The Associate Director/Director, Device Development will oversee device development for combination products involving parenteral devices and biologics and peptides.  This position will lead device development activities across the portfolio and require significant interaction within research and development functions particularly working with project teams as well as collaborating with manufacturing, regulatory, and quality organizations.

Major tasks and responsibilities will include:

  • Reviews and contributes to combination product regulatory submissions.
  • Provides technical expertise for the development of parenteral injection devices.
  • Develops risk assessment and failure mode analysis for the ongoing devices under co-development.
  • Supports preparation for meetings with regulatory agencies and attend as required.
  • Supports the development and implementation of guidance and requirements for the organization's strategies for combination products.
  • Supports development and integration of device/combination product development and commercialization interfaces.
  • Advises on and supports device/combination product compliance initiatives.
  • Supports the company’s device related networks.
  • Supports and coaches peers (direct reports will be available for this position).
  • Represent the company at external events as required.

We seek candidates with the following qualifications:

  • For Director level, Ph.D. in Chemical/Mechanical engineering, materials science, biomedical engineering , or related field plus 15+ years of related experience in the combination product or medical device industry with proven experience in launching drug-device based combination products or bringing devices into human trials globally and 8+ years of experience in design review for device development; application of device quality management system, labeling, human factors, and design verification/validation requirements.
  • For Associate Director level, Ph.D. in Chemical/Mechanical engineering, materials science, biomedical engineering , or related field plus 10+ years of related experience in the combination product or medical device industry with proven experience in launching drug-device based combination products or bringing devices into human trials globally and 5+ years of experience in design review for device development; application of device quality management system, labeling, human factors, and design verification/validation requirements.
  • 8+ years of experience in design review for device development; application of device quality management system, labeling, human factors, and design verification/validation requirements.
  • Exposure to regulatory aspects of device filing, IND, BLA.
  • Late stage filing experience will be satisfactory in the event launch experience is not present.
  • Strong understanding of device development and technical background for combination products, in particular biologic/device combinations for parenteral administration.
  • Strong matrix management skills in order to fulfill a leadership role with both internal and external partners.
  • Being pro-active and identifying issues early along with recommending and negotiation potential solutions.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2942. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.