Clinical Drug Delivery Device Lead
Il y a 3 jours
Jette, Brussels, Belgique
Akkodis
Temps plein
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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)
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)