Expiry Date: 28-02-2021
Category Regulatory Affairs
Job Type: Full Time
NEW - Associate Director CoDx Regulatory *Post Covid Cadillac Relo to PA/NJ or NJ/NYC*
About My Client
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 CoDx's 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).
You will have already worked in IVDs, and CoDx's 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.
Package & Benefits
You will benefit from an annual stock award with a quicker vesting period, a decent salary and performance bonus in a company which regularly gives good performance multipliers for dedicated employees, as well as a high end Associate Director basic. The company will buy out stock within reason and 2020 bonuses if you lose these.
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