Expiry Date: 20-10-2019
Categories Biotech, Clinical Research, Regulatory Affairs
Job Type: Full Time
Location: Princeton, NJ, USA
This is one of those positions we receive which is very compelling for the right individual, an individual with a strong track record in leading US or global submissions, who lives and thrives on the complexity of managing global regulatory programmes with multiple indications, across many Tumor types, and at the same time, you see your role as one of bringing a narrative to each programme, a message which regulators, patients and medics, will understand through your regulatory narrative.
You will know who you are. This role is not for the faint-hearted, you will be an individual who is thoroughly organized, understands the “ How to’s ” – influence and shape strategy with the R&D folks including clinical protocol designs (in a company where regulatory has a seat at the table); with the US or the major Regulators too, as a project team to showcase the innovation and potential of the MOAs, identify rationale for SPAs or adaptive designs, and, with the regional RA leads, to bind in their inputs to your overall strategy and then deliver and seamlessly execute the overall regulatory strategy you are accountable for and know how to show case.
You will be parachuted into this major programme, with very promising data, a highly supportive management team, and, even though this is a large bio-pharma, a close knit collegiate feel, to be the Global RA Strategy Lead for a programme with 10s’ of indications in Phases 2a/2b and with Phase 3s pending, and a clear remit to drive this programme through to NDA/MAA & sNDAs globally.
You will be an individual who can see beyond the initial strategy to what the patients and prescribers require in each patient segment and for each indication, and by collaborating with the cross-functional experts, help the project team translate these into a clearly differentiated studies, through to read out and major submissions / review. My client is known for innovative sciences that enable the innovation you want to see in the MOA, primary and secondary protocols incl. biomarkers and subsequent filings.
In return, my client is offering a world-class package underpinned by a merit-based advancement and compensation model, which combines high end salary, bonus and LTIs for the right individual. For the right candidate, my client will buy out RSU and Stock plans, and provide a red carpet relocation to the East Coast / Tri-State area.
To apply for this role, please register on this web site. My team and I would welcome a phone call in private if you would like to explore this role and opportunity, so please contact either myself, Matt Greig or Theo Moore on US Toll Free 855.505.1382
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