I am currently working with an innovative diagnostics company who are developing molecular profiling techniques to make breakthroughs within the precision medicine oncology space. As they move from a research-focussed environment to targeting the IVD space, they are seeking a Director of Assay Development.
My client are seeking a driven individual with a proven track-record leading assay development teams within an Molecular Diagnostics environment. The successful candidate will have experience in leading end-to-end development process, from feasibility to validation via the IVD route (510k or PMA). Requirements:
- >5-10years’ molecular diagnostics experience, with specific Gene Profiling (NGS, PCR, qPCR) experience required.
- Experience of product development and launch in an FDA regulated environment – 510k, PMA etc., with a strong product launch track-record.
- A proven understanding of the entire development process – from early-stage feasibility testing to development to validation/transfer to manufacturing.
- Experience developing diagnostic products for Oncology applications highly preferred.
- Strong leadership experience – at a minimum leading varying levels of scientists but additional experience in leading software development/project management functionals is desirable.
- The ideal candidate has both IVD and Laboratory Testing experience, with IVD experience a minimum requirement.
- Assay development experience required, with an understanding of systems development desirable.
The position is to be based in Southwestern US, relocation support will be given. Disclosing the exact location of the position will allude to the company I’m working with, but I can share all specific details upon application.
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