Kaléo
Biotech
Director,CombinationProductDevelopmentandHumanFactorEngineering
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Combination Product Development and Human Factor Engineering at Kaléo. Skills: Combination Product Development, Human Factor Engineering, Drug Delivery Devices, Risk Management. Manage and execute Design Controls. Manage and execute Drug Development Program”
Industry & Context.
Problem-solving techniques; Creative problem solving
Less than 25% travel
What They're Looking For.
Must Have
Bachelors, Masters, or PhD, Patient centric drug/device combination product development, Minimum 10+ years medical device development, Experience managing external CMO’s, Experience in design controls, Experience in risk management, Experience in ISO 13485, Minimum 5+ years managing human factor engineering studies
Nice to Have
Biomedical Engineering, Mechanical Engineering, Material engineering, Systems Engineering preferred, Demonstrated record of accomplishments preferred
What You'll Do.
Manage and execute Design Controls
Manage and execute Drug Development Program
Lead human factor engineering activities
development and manufacturing partners
Ensure program execution for development
Execute Risk Management Programs
Execute Risk Analyses
Provide leadership for new products
Help build intellectual property portfolio
Manage project and program budgets
Manage project and program timelines
Author regulatory submissions
Review regulatory submissions
Report progress to senior management
Report risks to senior management
Report opportunities to senior management
How You'll Work.
Team & Collaboration
Internal stakeholders; External partners; Cross-functionally
Communication Scope
Verbal communication; Written communication
Process & Methodology
Project management, Program management
Full Job Description
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 responsible for human factor engineering activities as per the regulatory guidelines Work with design, development and manufacturing partners to ensure program execution for the development of Kaleo’s drug delivery devices stay on timeline and within approved budget Execute Risk Management Progra
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