Clinical drug delivery devices lead
Brabant Wallon – contracting
What are your responsibilities?
As a Clinical Drug Delivery Device Lead, you will report to the Head of Device Transversal Services and you will work as a subject matter expert to select and/or assess drug delivery devices used in clinical trials (ie. injection pumps, infusion lines and bags, needles and syringes for iv and sc administrations, oral syringes and dosing cup, etc…). You will be part of a global and highly collaborative multidisciplinary team.
What you’ll do
-
Define and implement the overall strategy for the various drug delivery devices to be used in the clinical trials.
-
Work with a cross-functional team (including clinical, QA, RA, safety and SME teams) to ensure timely support to clinical trials.
-
Lead the Clinical Drug Delivery Devices sub-teams to ensure appropriate selection and assessment of drug delivery devices to be used in the clinical trials.
-
Perform the technical assessment for devices used in clinical trials and selected by our CROs.
Who are you ?
- A master’s degree with a relevant academic background, ideally a nurse or a physician
- 8+ years of experience in a clinical drug delivery devices selection
- Very good knowledge of medical devices and pharmaceutical environments
- Experience in clinical trials set-up
- Understanding of the issues and challenges of selecting appropriate and fit for purpose devices from FIH to Phase 4 clinical trials studies
- Thorough knowledge and understanding of Medical Devices Regulations (EU MDR, 21CFR part 820, ISO13485) and in GxP (GMP and GCP)
- Experience in drug-device compatibility testing and material of contact assessment is a plus
- Project management skills
- Leading and influencing cross-functional and matrix teams
- Excellent writing skills
- Autonomous and detail oriented
What can you expect ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
