Key Leader in Clinical Assay Development
A key technical leader for new clinical assay projects is sought. The ideal candidate will ensure scientific rigor and regulatory compliance throughout the product development lifecycle.
* This role will advise on all matters related to clinical flow cytometry assay development.
* The position requires assessing technical feasibility of projects, identifying risks, and proposing solutions.
* Sufficient scientific rigor must be ensured for all technical and design reviews.
* The selected candidate must ensure that R&D activities satisfy regulatory standards including documentation and reporting requirements.
* Effective collaboration and communication across functions is essential to ensure awareness and understanding of the execution strategy/plans.
* Growth of the technical capabilities of the team by demonstrating best practices, facilitating training sessions, and mentoring junior associates is expected.
* Succinct program updates to the program manager or other business leads as required are necessary.
* Representation of the organization externally at conferences and scientific meetings is required.
* Representing the organization externally with regulatory agencies, notified bodies, FDA, etc., is also required.
* Incorporating customer perspectives into all aspects of product development is vital.
* Engagement with related industrial and medical institutions to stay updated on emerging trends in the field is essential.
* Identifying promising new clinically relevant technologies and/or assays is a key responsibility.
Required Skills and Qualifications:
* An advanced degree (Masters or MD/PhD) in a relevant scientific field is required.
* A minimum of ten years' experience bringing clinical products to market is required.
* Extensive flow cytometry application and data analysis experience is necessary.
* Extensive clinical diagnostic R&D experience in an industry setting is required.
* Demonstrated analytical and technical problem-solving skills are essential.
* Demonstrated ability to effectively work in a team environment is required.
* Experience working across geographies in different countries and time zones is preferred.
* Excellent verbal, written, and presentation skills are required.
* Experience working with regulatory bodies is essential.
* Understanding of regulations, standards, and guidelines related to IVD, and/or medical devices and quality systems including 21 CFR, CE-IVD, ISO 13485, etc., is necessary.