Expiry Date: 20-06-2020
Categories Clinical Research, Regulatory Affairs
Salary: On Application
Job Type: Full Time
Global Regulatory Strategy Leader * Checkpoint Inhibitor / IL Combo ** Client at « ASCO » NJ/PA/NYC
This is a one of a kind opportunity for a high achiever who wants to lead a major programme that will crown your career. It is very compelling for the right individual, an individual with a strong track record in leading US NDA or global submissions.
My client is at « ASCO » and is offering 20-30 minute meet ups, during congress. If this role interests you, or you are curious, please contact me, Matt Greig, on 908.332.9157 - including this Saturday and Sunday AM.
You will thrive and live on complexity in the design of multiple indication programmes, 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 the regulators and your regulatory sub-teams will both understand and follow:
You will know who you are! 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 design (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 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.
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 Cadillac relocation to the East Coast / Tri-State area.
To apply for this role, please press the red “Apply for position” button, or contact me, Matt Greig, on US Direct 908-332-9157. I also work Saturday and Sunday AMs for this level of role, and would welcome your call outside working hours at the weekends.
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