Expiry Date: 22-12-2020
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Global Regulatory Head CoDx’s & DigiMeds - Oncology & Precision Meds ** NJ / NYC / PA
This role is for a visionary and eulogist for bringing the 2 sciences of drug development and CoDx’s together. You will instantly know this is a rare opportunity because these types of roles do not appear that often especially in a company the size of my client, and with their appetite for applying ground-breaking sciences in a pipeline that includes Oncology, Immunology and Cell / Gene Therapy!
You will manage a team which is set to grow and lead yourself and with the team, the combination of diagnostics development with the drug development teams, as the strategic partner working alongside the global and regional therapy leads and their US/GRLs, in a company which has over 100 registration studies running right now, many requiring CoDx’s (companion, complimentary, not injectors).
As well as leading the team and managing a program or two yourself, you will be a core team member for their drive to utilize Digital Meds and CoDxs in their programs, and as a senior executive of the function, you will partner your regulatory counterparts and the wider functions, especially clinical science, acting as both an educator, facilitator or leader to move the paradigm from ‘how’ to the ‘why?’.
You will have oversight for ensuring the timely development of the regulatory strategies for precision medicines but knowing you have an enterprise wide team to support you, for translating strategies into actual supply of Clinical Trial Assays and IDE CTAs to approved / used IVDs.
You will ensure review and maintain oversight for SRDs, input into core development plans, INDs, IDEs, and eventually as well as either through a vendor or directly the registration of the PMAs.
To apply for this role, please press the red “Apply for position”, or contact Octavian Dinca on 855.505.1382 or my colleague (for weekends AMs and evenings), Matt Greig, on 908-332-9157. ADV Talent operates a Global Data Protection policy and will not forward your details without your written consent.
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