Director/Associate Director of IVD Product Development
An exciting opportunity has become available within a diagnostic company based in Menlo Park, CA. The company is using next generation sequencing and novel assays to develop a multi-cancer early detection blood test in order to increase patients' chances of successful treatment. The company is looking to hire a seasoned technical Director to lead the IVD Product Development teams through planning, design, and execution of technical validation activities for regulatory submissions.
Ideal candidates will have a strong track record of successfully leading a product development team through a regulatory submission and FDA aapproval for an IVD product (class III PMA product).
ROLE RESPONSIBILITIES INCLUDE:
- Lead IVD product development teams through planning, design & execution of technical validation activities for regulatory submissions
- Perform & review complex analyses of study data sets to address verification/validation study objectives in collaboration with bioinformatics & biostatistics teams
- Report project updates, data analyses & experimental conclusions at technical meetings
- Drive study documentation in compliance with good laboratory practices & quality systems requirements to support regulatory filings
- Ph.D in Molecular Biology, Biochemistry or related fields with 8+ years of industry experience required
- Strong track record of successful IVD product regulatory submissions is essential
- Hands-on, practical knowledge of requirements of working under design control required
- Experience launching LDT products in high volume clinical settings is highly desired
- Next generation sequencing assay development desired
Competitive Salary + Bonus + Relocation Assistance
Local Candidates Preferred