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

Reference: MG230920AR

Expiry Date: 05-11-2021

Categories Biotech, Clinical Research, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Fulton County
United States

Apply for position

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 has 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)


  • 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!


  • 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 or call Oli Dimitrov or Matt Greig on US toll free 908-332-9157. Alternatively, press the red “Apply for position” button and follow the registration process.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number US 908-332-9157 or UK+44 (0)207 801 3380.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.