Expiry Date: 23-12-2021
Categories Biotech, Clinical Research
Job Type: Full Time
Director or Assoc Director ** Full clinical phases ** Oncology NMEs ** Top 10 pharma ** Full Remote, or Relocate!
About My Client
My client is, dare I say it, a blue-chip, well-ranked in the top 10, with a multi-billion dollar R&D spend, and a pedigree in innovation for Oncology, combined with their research and licensing effort, a capable precision medicines and translational meds groups, so this is a power house for science and innovation in solid tumor and haemo, with biomarkers and novel MOAs! They have a large existing portfolio, this is not a one trick pony!
These are full development regulatory roles, what I mean by that is, you will be providing US and global input into CDP and Protocols, as the regulatory partner for NMEs in Ph 1a/1b (incl. for some NMEs Octopus studies), extended Ph 2s, and 3s, and the EU equivalents where possible (you do not need previous EU experience to apply).
Baseline, we are recruiting for strong Regulatory Liaisons who will be 1st time or 2nd time GRLs, who want to really grow in the global Oncology regulatory environment, with world-class systems, processes and quicker governance routes, and in return, you will want to gain full project lifecycle experience (from Ph 1 on to NDAs/sNDA or BLAs/sBLAs) - this is a high potential career opportunity requiring high performing individuals who do not want to plateau!
You will resonate with this and view yourself as high potential, high actual, and are hungry to attain a position which will give you visibility and accountability you think your career deserves.
If you lean towards the science, and love to be immersed in MOAs, and the ‘blue sky’ thinking Ph 1 molecules need, then my client will give you more early phase projects!
If you like the cut and thrust of 3a/3bs to s/NDA filings, my client will assign you more late phase projects, so either way we can satisfy your career goals!
You will be a US Liaison or have started as a GRL and are considering your options, maybe you want to work in a company with better funding or quicker governance; alternatively you might have been overlooked on grade and feel you are ready to be promoted. You will have managed regulatory procedures for clinical development, started or have created new regulatory strategies, and have led either major INDs and prepared EOP1 or EOP2 meetings, OR have filed sNDAs already. Note the OR! Either way these opportunities are full project lifecycle positions across all the clinical phases.
We have a lot of flexibility on Full Remote Vs Part-Office / Part-Home Vs both during and post-Covid. Don’t let location be a deciding factor, the company are moving to a much more flexible model, and as I emphasized, if you did have to go in, it’s not a million miles away from you! We have a video / digital hiring process in place!
We have the both the Associate Director and Director grading, so salaries are commensurate with your background in terms of education and regulatory, your current grade and your future potential. That said, this is a major organization who offers decent high end basic salaries, the ability to over exceed bonus and a stock plan. My client will buyout stock and performance bonuses for 2020 for the right candidate in full. The Health Insurance package I believe is better than the norm.
Please contact me, Theo Moore, or my colleague Matt Greig, on 855-505-1382 or send a full CV to firstname.lastname@example.org and we will reply by return - alternatively, if you find speaking difficult at work, you can contact Matt on 908-332-9157 early AMs, later PMs and Saturday and Sunday AMs only. All applications are treated in confidence, and we are able to support you every step of the way through the process!
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