Position: Clinical Drug Delivery Device Lead
Location:
* Braine l'Alleud (BE)
* Slough (UK)
* Bulle (CH)
* Remote (EU-based)
About the Role:
We are looking for a methodical, detail-oriented Clinical Drug Delivery Device Lead with excellent interpersonal skills to join our Devices, Artwork, and Packaging team. This position will focus on supporting the selection and assessment of drug delivery devices used in clinical trials.
Who You'll Work With:
As a Clinical Drug Delivery Device Lead, you will report to the Head of Device Transversal Services. You will serve as a subject matter expert in selecting and assessing drug delivery devices for clinical trials, such as:
* Injection pumps
* Infusion lines and infusion bags
* Syringes and needles (IV and SC administrations)
* Oral syringes and dosing cups
You will be part of a global, highly collaborative multidisciplinary team.
What You'll Do:
* Provide technical expertise on various drug delivery devices for clinical trials.
* Lead sub-teams in the selection and assessment of drug delivery devices, ensuring they are fit for purpose.
* Work cross-functionally with clinical, QA, RA, safety, and SME teams to provide timely support for clinical trials.
* Perform technical assessments for devices used in clinical trials, including those selected by CROs.
* Respond promptly to Clinical Drug Delivery Device Change Requests.
* Ensure the timely completion of the Clinical Drug Delivery Device Database.
Interested? For this Role, We're Looking for the Following Qualifications:
* A master's degree with a relevant academic background.
* 8+ years of experience in the selection of clinical drug delivery devices.
* Technical expertise in drug delivery devices, including injection pumps, plastic syringes, needles, and infusion lines.
* Strong technical knowledge of medical devices and clinical pharmaceutical environments.
* Experience in clinical trial set-up.
* Understanding of the challenges of selecting appropriate and fit-for-purpose devices from First in Human (FIH) to Phase 4 clinical trials.
* In-depth knowledge of Medical Device Regulations: EU MDR, 21 CFR Part 820, ISO 13485, and GxP (GMP and GCP).
* Experience in drug-device compatibility testing and material contact assessments is a plus.
* Strong project management and risk management skills.
* Ability to lead and influence cross-functional and matrix teams.
* Excellent writing skills.
* Autonomous and detail-oriented.