Director, Combination Product Development and Human Factor Engineering
About the role
Director, Combination Product Development and Human Factor Engineering
This is a remote opportunity with occasional travel, estimated at less than 25%.
Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind.
The Director, Combination Product Development and Human Factor Engineering is responsible for managing the development of new combination products including design, development, and human factor studies through design transfer into manufacturing. The individual should be involved in building Kaleo’s intellectual property portfolio development. The Director will support the senior leadership team with critical information to make informed decisions on the selection of key partners, risks, and identification of critical milestones (budgeting, R&D build strategy, etc).
This individual will need to develop strong relationships with external partners to ensure completion of all aspects of device/drug development and support of Human Factor studies from planning to execution. Internal interactions with Business Development, Manufacturing, and Regulatory Affairs provide opportunities to expand knowledge and make an impact on business development and post marketing activities. Key relationships to this position include Regulatory Affairs, External Partners (Suppliers, CMO and CDMO), Legal, Supply Chain, and Manufacturing.
As Director, Combination Product Development and Human Factor Engineering you will:
- Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development in accordance with Kaleo’s Quality System and 21 CFR 820.30/ISO 13485
- Lead and be responsible for human factor engineering activities as per the regulatory guidelines