This Job Vacancy has Expired!

Senior Director of CoDx Regulatory

Posted on Apr 5, 2021 by ADV Talent Partners

New Jersey, NJ
Research
Immediate Start
Annual Salary
Full-Time


This is a role with a Top 5 global pharma company which occupies an exclusive niche position with a focus on novel products across with 4 major therapy areas and over 100 years history and track record of bringing new medicines to market while having one of the most innovative pipeline in the industry currently. Their pipeline and this role includes oncology.


Note: My client offers Digital Hiring and On-Boarding using Video Conferencing and the successful candidate will be inducted and trained remotely. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns!


About this Opportunity


Are you excited by a strategic role that permits you to drive and shape scientific innovation, provide tactical and strategic input into developing the regulatory pathways for CoDx in oncology and other speciality disease areas?
Do you want to work with therapy regulatory leaders to provide input, translate Precision Meds biomarker targets into IDEs and final Dx registrations?
Are you interested in widening your experience form CoDxs into digital medicines, for your assigned programs?
Can you lead/coordinate and drive complicated CoDx programs with the partners, for adaptive design Clinical Trials and quick changing oncology programs requiring Clin Trial Assays, risk assessments and IDE filings? (Although you will work across all TAs).
About you!


You will have already worked in IVDs, and CoDxs in a regulatory role, and this could be with a sponsor side role in a biotech or pharmaceutical company, or with one of the CMOs and vendors who specialize in IVDs for companion or complimentary use, and have good exposure/or direct experience of working with drug development teams. You will have a solid track record in work history terms, and be willing to relocate this year or next to either NJ/PA borders or NJ/NYC, if needed.




Reference: 1152694936

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