Expiry Date: 22-12-2020
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Windsor and Maidenhead
Global Regulatory Director CoDx’s & DigiMeds - Oncology & Precision Meds EU / UK
About my Client
This is a role with a company part of the Top20 global biopharma companies which occupies an exclusive niche position in the world of big pharma with a focus on sophisticated pharma and biological products for serious illnesses with four major TAs and over 150 years history and track record of bringing new medicines to market while having one of the most innovative pipeline in the industry currently.
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
This is a great opportunity for a seasoned and influential regulatory leader to navigate and bridge two worlds: the CoDx’s biomarker within precision medicine and drug development. This is indeed a rare opportunity because such roles appear every so often. A person that is versatile and uses a flexible approach to rise synergies in supporting the development of biomarkers and companion diagnostics as well as other devices and enable the therapeutic drug to get on the market. This is a growing function as the development of Companion Diagnostics and the next generation of drugs has to be safer and more efficacious.
About the Role
The client would like an individual with a solid track record and working knowledge of delivering regulatory approvals such as IDEs and a deep exposure to developing companion diagnostics and devices. A strong leader is needed to bring the direct experience in developing and driving the Drug and Device Development strategy while guiding teams through interactions with the HA and Regulatory Agencies.
At the team level, you will display likeability and have a personality which people will be drawn to, combined with the type of scientific insights precision medicine demands. At a management level, you will have definitely started to matrix manage and mentor other leaders as a coach all the while being an individual contributor to the projects.
You will ensure review and maintain oversight for SRDs, input into core development plans, INDs, IDEs, and eventually as well as either through a vendor or directly the registration of the PMAs.
Your Background & Experience
You will have a regulatory track record and be able to demonstrate in your career thus far how successfully you have provided strategic input on key development documents, IBs, INDs, CTAs, IDEs, SRD, PMAs in order to ensure that the global regulatory strategy supports a precision medicine approach to continue the development of biomarkers and companion diagnostics tests.
If you are a strategic and analytical thinker, with more than 7 years of global drug development experience, and are recognized for your ability to build relationships across functions and lead teams to think ‘out-of-the-box’ to achieve goals, solve problems and continuously innovate please consider making your application.
My Client Offers in Return
A high-end basic salary as well as a high performing stock plan and bonus scheme with shorter vesting and a willingness to buy out any stock plan you currently have! My client will consider compelling candidates at Director or high-end Director level and provide a set of incentives around role and package which will stand you in good stead and give you the type of jump start a major move should bring to you.
To apply for this role, please press the red “Apply for position” button, or contact Octavian or Matt on +44 (0)207 801 3387 or +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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