Are you an Associate Regulatory Director ** Next Step Director & GRL on a High Value program in Solid Tumour ** East Coast (NY, NJ, PA area)
This is a flagship development, currently in Phase 1B, and soon to start full development for an array of indications in solid tumour. If you think checkpoint inhibitors, precision meds, PDL-1, PD-1, you are in the right room but we would consider individuals with Haemo-Oncology as well.
You will consider yourself a rising star, who has always delivered on your projects, but maybe you are working in a company which has been slow to recognize this, or maybe your company is in too small or squeezed financially to give you that important next break, next promotion or the project you think you deserve, based on your previous merit?
Have you filed a NDA or multiple Line Extensions and want to work on something very fresh but moving up to a GRL position?
Well, we have a role which you might identify with, where you can capitalize on your expertise and track record, gain the Director position, and take responsibility for defining and shaping Global RA Strategy for a NME, in solid tumour with around 10 indications for you to manage (with a group of regional RLs, supporting you).
In return, you will have the following experiences / capabilities:-
- Co- or led a NDA submission alternatively, led Line Extension New Indications into filing with approval(s)
- Have a strong understand of early or late phase development including direct experience of the US regulatory framework, and an understanding of the EMA’s requirements
- Partnered with clinical to provide regulatory input into clinical protocols
- Attended and led or co-led if you are in a hierarchical company, HA meetings with the FDA and possibly other major health authorities
- Already be a GRL on an early stage programme but want to gain a footing in a bigger organization on a major programme.
My role is based in the East Coast area, and comes with a full relocation if needed. This role can be commuted easily from most PA, NJ and New York metropolitan areas. We have already hired for this company this year, and they have a fair and equitable approach to attraction, will buy out stock plans for the right person, and will work hard to identify ways to develop you, including people management if this is your objective.
We want to hear from you! To apply for this role, please call Matt Greig or Theo Moore on US Toll Free 855-505-1382 for a confidential discussion. Alternatively, please send your CV with a covering note to CV@AdvTalent.com - all applications are treated in confidence, and we require no personal information outside your CV during the application process.
About Advanced Search & Our Network
Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.
Our team know our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.
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+44 (0)207 801 3380 or US 855-505-1382.
All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.