Associate Director of CDx Regulatory ** Relocate to Southern States or work Remote Permanently ** (code USA 120220-2)

Reference: MG230920A

Expiry Date: 23-11-2020

Categories Biotech, Clinical Research, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Fulton County
United States

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Job Description

Associate Director of CDx Regulatory ** Relocate to Southern States or work Remote Permanently **

I am working with one of the best CDx regulatory and IVD development experts around, who is now building his team and the CDx platform for a smaller, leaner mid-sized Biotech. This is an exceptional role I think for two reasons, one being the quality of the coaching available from the line manager, and the other, being the diversity of the CDx development pipeline. Of course, this is an Associate Director role, so if you have solid expertise and a track record, you can be based remotely  permanently, or move to Durham next summer. Both options are funded!

The company have 4 lead CDx programs as well as many more in early development, supporting a drug pipeline with multiple BLA/NDA and sNDA submissions in Ph 3 penned for the next 2-3 years, this will be your intellectual playground! As an Associate Director, you will lead a program, with the support of regulatory scientists, the Precision Meds team, and the Vendors.  There are affiliates for all the main regions, who will help you with some of the international majors (China, Japan).

You will consider this role if:-

  • You have worked with a leading CDx Vendor on IVDs used by Drug Developers as Companion or Complimentary Diagnostics and you have been either in a regulatory or combined RA/QA role and have filed CDx’s ideally in the USA and / or multiple regions (IDE, PMA, 501(K), CE Marked)

OR

  • You are working in a CDx team in a R&D Pharmaceutical or Biotech company, and want to advance through the grades, in an organization which is merit-based and pays their regulatory folks in devices the same they pay their folks in drug development!

AND

  • You have the type of personality people are attracted to professionally, you know how to educate drug development regulatory and project teams on the regulatory pathway from identification of the Biomarkers to the actual IVD being registered as a CDx
  • You want to be rewarded for and accountable for your deliverables, reaching the key milestones, and have co-led CDx registrations (this could be at arms’ length via your main vendor).

Package & Benefits

The role comes with, depending upon your location preferences, a decent salary, bonus, stock plan and health insurance, the relocation is for selling / buying a house or renting an apartment / house.

For the right individual, the company will buyout a certain level of 2020 bonus you might lose, as well as some stock!

To Apply!

To apply for this role, please send a full CV to cv@advtalent.com or call Matt Greig or Oli Dimitrov on US toll free 908-332-9157. Alternatively, press the red “Apply for position” button and follow the registration process.

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