Global Regulatory Head CoDx’s & DigiMeds - Oncology & Precision Meds ** NJ / NYC / PA

Employer
Advanced S&S (USA)
Location
NJ, NYC, PA, USA
Salary
On Application
Closing date
14 Oct 2020

View more

Discipline
Regulatory Affairs, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
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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!

To apply for this role, please contact either myself, Octavian Dinca, on 855.505.1382 or my colleague (for weekends AMs and evenings), Matt Greig, on 908-332-9157, or alternatively, please send a full CV to me at CV@AdvTalent.com with a current cell number and preferred time to speak. ADV Talent operates a Global Data Protection policy and will not forward your details without your written consent.

About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our team knows our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

Contact us today to see how we can help you, make that next career move on

+44 20 7801 3380

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8, Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +1 855-505-1382
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