Global Regulatory Leader ** Checkpoint Inhibitor / IL Combo ** Meet my client at « ASCO » Relo offered ** NJ/PA/NYC

Reference: MG170519A

Expiry Date: 20-08-2020

Categories Clinical Research, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Mercer County
United States

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Job Description

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:

  • Join Phase 1B global programme, and take a sub-set for half the indications through for 3 distinct tumour types for combo which has already achieved highly promising data
  • Crown your career by seeing this program though, in a company and environment at the cutting edge of Oncology sciences, as the RA GRL in the project team with R&D for biomarkers, clinical protocol design, stratification / segmentation in a shared space
  • Develop the global RA strategy by working directly with Clinical Science for adaptive designs, potentials for rapid development, Protocol Assistance and given existing potential efficacy, most likely Accelerated Review
  • Lead global HA interactions, through your teams and develop your strategies for each indication and region by leading your matrix reports, based in the US, Europe, Japan and China
  • Be mentored by two senior individuals who have their own strong track records, offer pragmatic support and know when to work hard and when to rest up!

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!

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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