Senior Project Manager, Clinical Drug Device Development (O Fallon)

AbbVie in O Fallon, IL

  • Industry: Pharmaceutical/Biotechnology - Brand/Product Manager
  • Type: Full Time
position filled
AbbVie is hiring for a new position within the Combination Product Development (CPD) team. AbbVie CPD designs, engineers, and delivers drug device products associated with our pipelined drugs entering clinical trials. This group is composed of human factors engineers, system engineers, and product engineers.

We are now seeking an individual to lead the efforts in supporting design validation, clinical trials, and regulatory submission for the development and launch of new drug delivery systems. This individual will represent CPD in the support of clinical trials, regulatory submissions, and commercial launch of new products.

Successful applicants will bring one of the following specialties/backgrounds: Clinical trial management, quality assurance within the pharmaceutical industry, or drug device engineering. Crucial to this role will be the ability to understand technical concepts and communicate to a wide variety of audiences, forge new cross-functional relationships, create new standards of practice, and thrive in developing new processes.

Responsibilities include the following:
  • Clinical Trial Support: Coordinates CPD activities related to clinical study preparation and execution including support to complaint handling
  • Design Validation:
    • Plan/Design and communicate outcomes of simulated-use study
    • Work with clinical and other organization in planning and executing "real-life"/"home-use" studies
    • Support Joint Human Factor Engineers (HFE) in the efforts of planning and summarizing HFE Validation/Summative study
  • Regulatory Submission Support: Authors/approves regulatory submission documents and coordinates devices sessions with regulatory team
  • Commercial Launch Support: represents CPD in the preparation of training materials and training for commercial launch
  • Product life cycle strategy support: obtains and communicates on-market product experience; and assist in the development of product life cycle strategy

In addition, it is expected that this individual be engaged with clinical, project development, quality, regulatory, and commercial teams, and external engineering partners. These activities will require the development and fostering of relationships with these groups.

Required Skills / Experience:
  • BS in Engineering (Mechanical, Chemical, etc) with 7+ of experience OR BS in Science (Chemistry, Biology, etc) with 10+ years of experience.
  • Understanding of the clinical trial process required - experience managing clinical trials a strong plus.
  • Considerable experience in regulatory submissions strongly preferred particularly with exposure to combination drug products.
  • Experience in design validation a plus.
  • Medical product experimental skills, as well as a sound understanding of medical product laboratory practices and equipment (for those with engineering background)
  • Strong analytical, decision making, and communication (spoken and written) skills.
  • Travel may be required, as necessary.

Job level will be commensurate with experience.
Associated topics: business, business development, commercialization, direct, manage, marketing, marketing specialist, product development, product marketing, supply chain

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