Clinical Drug Delivery Device Lead
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About Akkodis
Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
Akkodis is part of the Adecco Group. Our Webstite : www.akkodis.com
About the Role
We are looking for a Clinical Drug Delivery Device Lead who is methodical, detail-oriented, and possesses excellent stakeholder management skills to join a global Devices, Artwork & Packaging team.
This role focuses on the selection, assessment, and implementation of drug delivery devices used in clinical trial programs. The successful candidate will act as a subject matter expert, ensuring that appropriate and fit-for-purpose devices are selected and evaluated throughout the clinical development lifecycle.
Key Responsibilities
- Define and implement the overall strategy for drug delivery devices used in clinical trials.
- Lead the selection and assessment of clinical drug delivery devices, ensuring compliance with project requirements and regulatory standards.
- Provide technical expertise on devices such as: Injection pumps, Infusion lines and bags, needles and syringes for IV and SC administration, oral syringes, dosing cups, other clinical administration devices
- Conduct technical assessments of devices proposed by external vendors and CROs.
- Collaborate closely with cross-functional stakeholders, including Clinical Development, Quality Assurance, Regulatory Affairs, Safety, and other technical experts.
- Lead multidisciplinary project teams to ensure timely support for clinical trial activities.
- Drive decision-making and influence stakeholders across matrix organizations.
- Support clinical trial setup activities and ensure device suitability from First-in-Human (FIH) studies through Phase IV clinical trials.
Required Qualifications & Experience
- Master's degree in a relevant scientific or healthcare discipline.
- Healthcare background (e.g., nurse, physician, or equivalent) is considered a strong asset.
- Minimum 8 years of experience in the selection and assessment of clinical drug delivery devices.
- Strong knowledge of both medical device and pharmaceutical environments.
- Experience in clinical trial setup and execution.
- Solid understanding of challenges related to device selection across different clinical development phases.
- Excellent project management and organizational skills.
- Ability to lead and influence multidisciplinary and cross-functional teams.
- Strong written and verbal communication skills.
- Ability to work autonomously while maintaining a high level of attention to detail.
Regulatory & Quality Knowledge
Strong understanding of:
- EU Medical Device Regulation (EU MDR)
- FDA 21 CFR Part 820
- ISO 13485
- Good Clinical Practice (GCP)
- Good Manufacturing Practice (GMP)
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