US Remote or NJ/MA based ** CDx Regulatory Director ** Global Top Bio-Pharma ** Early Meds & BioMarkers Focus ** (code USA 210920-1)

Reference: MG210920A

Expiry Date: 21-12-2021

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Mercer County
United States

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Job Description

US Remote or NJ/MA based ** CDx Regulatory Director ** Global Top Bio-Pharma ** Early Meds & BioMarkers Focus **


These vacancies are well-paid, and open to driven, ambitious individuals who want to grow in a team which will offer opportunities to advance; in return, you will consider these roles if you have CDx regulatory experience in the clinical phases or work in an IVD/CDx Vendor and want to gain more exposure to the drug development and biomarker development areas.

Note on Covid:

My client is able to hire you digitally and on-board you remotely anywhere in the USA, until Covid is over, certainly by Summer 2021. Then, depending upon your aptitude and merit, you will be asked whether to relocate to 1 of 3 locations (this is funded and includes sites in MA, or NJ), or you can stay in place permanently if you are willing to visit site regularly!

About You!

You will live and breathe the science of Companion Diagnostics, and how these can help transform  the patients and clinicians options and understanding in treating Oncology more successfully (Solid Tumor and Haemo) and you want to work in a company which has the size of Novel pipeline to display the variety in Methods of Actions, innovation and supporting Biomarkers to make your role truly involving, engaging and compelling, under the guidance of an ex-FDA now Biotech industry (and highly qualified) CDx Visionary!

We are seeking a bit of a superstar, someone that wants to bridge the understanding for CDx strategy between the therapy regulatory folks, and the precision medicines group, in a company that is highly collaborative and regulatory strategy is a big component in making decisions in clinical development and you will have a seat on that table.

You will have already developed CDx regulatory strategies, or worked in a role where you might be looking after both developing and registering CDx’s, Digital Medicines or Companion Devices, and now want to spread your wings. The role is to support a large Oncology group plus a number of other therapy areas, and they do anything CDx or Digital, so this will be your focus.

The role is global but if you have only managed Dx US submissions and strategies, for the clinical phases or work now at an IVD company which supports Oncology Drug Developers, we would equally be interested!

Package & Remuneration 

My client, if you are successful, will make a highly rewarding and attractive offer whether you are currently an Associate Director, or already a Director, including bonuses and stock, a decent for US standards number of vacation days, and will buyout any losses from the 2020 bonus year and any loss of stock. The company have as said, a digital hiring process, so you can stay in place, be remote with some office visits, or relocate in time, the choice is yours!

To Apply!

To apply for this role, please contact me in private in the first instance, asking for Matt Greig on US dial  908-332-9157, or press the red “Apply for position” button. If you do call and I am on another call, please leave your Cell number if possible!

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