Director or Associate Director - Oncology
Posted on Jun 20, 2021 by ADV Talent Partners
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 Powerhouse 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.