Associate Director- Director, Device Development

Job Description
Job Description

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

Position Summary:
Be part of Medimmune team to oversee device development for combination products involving parenteral devices and biologics and peptiedes. This position will lead device development activities across the portfolio and require significant interaction within research and development functions particularly working with project teams in Medimmune, as well as collaborating with AstraZeneca's manufacturing, regulatory, and quality organizations. This individual must be able to effectively work in a matrix environment and should have leadership qualities. Product development experience in the areas of, autoinjector, patch pumps and or pen devices will be highly desired. Experience with both early stage and late stage device development in these areas is a must. This individual will be responsible for preparing submission document to various agencies,-- in particular injection based systems for parenteral administration.

Major Duties and Responsibilities:
(including those involving prefilled syringes, autoinjectors and large volume bolus injectors, and pen devices)

* Review and contribute to combination product regulatory submissions (INDs, CTAs, BLAs, MAAs, etc...)
* Provide technical expertise for the development of parenteral injection devices
* Develop risk assessment and failure mode analysis for the ongoing devices under co-development
* Support preparation for meetings with regulatory agencies and attend as required
* Support the development and implementation of guidance and requirements for organization's strategies for combination products
* Support development and integration of device/combination product development and commercialization interfaces
* Advise on and support device/combination product compliance initiatives
* Support AZ/MedImmune device related networks
* Support and coach peers within MedImmune (Direct reports will be available for this position)
* Represent MedImmune at external events (PhRMA, PDA, ISPE, BIO, DIA, IPAC-RS, AAMI/ISO, etc.), as required

~BSP
Requirements

Education:

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 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 experience in design review for device development; application of device quality management system, labeling, human factors, and design verification/validation requirements

Other:

* 8+ years 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.
* Application of critical thinking skills;
* 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.

Company

MedImmune

Job Code

State or Province

Maryland

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