Clinical Drug Delivery Device Lead

Job Title:Clinical Drug Delivery Device Lead

Location: Brussels , BY

Employment Type: 

Contract

We are seeking a methodical and detail-oriented Clinical Drug Delivery Device Lead.

You will provide support in the selection and assessment of drug delivery devices for clinical trials. You will serve as a subject matter expert to ensure that the appropriate devices are chosen and evaluated for trials, including injection pumps, infusion lines, bags, needles, syringes, and oral dosing tools.

Responsibilities:

• Define and implement strategies for the selection and use of various drug delivery devices in clinical trials.
• Collaborate with a cross-functional team (including clinical, QA, RA, safety, and SME teams) to ensure timely and effective support for clinical trials.
• Lead sub-teams focused on Clinical Drug Delivery Devices to ensure the correct selection and assessment of devices.
• Perform technical assessments for devices used in clinical trials and selected by our CROs.

Skills:

• 8+ years of experience in the selection of clinical drug delivery devices.
• Extensive knowledge of medical devices and pharmaceutical environments.
• Experience in setting up clinical trials.
• Understanding of the challenges associated with selecting suitable devices from First-In-Human (FIH) through to Phase 4 studies.
• In-depth knowledge of Medical Devices Regulations (EU MDR, 21CFR part 820, ISO13485) and Good Practice (GxP) standards (GMP and GCP).
• Experience in drug-device compatibility testing and material of contact assessment is a plus.
• Strong project management skills.

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