Global Regulatory Lead / Director ** Be the GRL on a NME on a novel checkpoint (moving beyond PD-1) (Code USA 040620-1)

Reference: MG040620A

Expiry Date: 04-05-2021

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Philadelphia County
United States

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Job Description

Global Regulatory Leader / Director ** Be the GRL on a NME targeting a novel immune checkpoint (and moving beyond PD-1) with great data!

To apply for this role, please press the red “Apply for position”, or contact me, Matt Greig, on 908-332-9157 and I will reply by return. I am able to speak with you weekdays as well as Saturday and Sunday AMs. All enquiries are taken in confidence!

My client’s role does what it says on the box, you will be the global strategy lead for a NME working its way through the clinical phases for multiple indications and as a single therapeutic agent and in a raft of drug-drug combinations. You will be a core team member where you will lead the 1st round submission in a short period of time, while managing the Global RA sub team to support this first round filing plus the sNDAs (there are a quite few!) currently in Phase 1B/2a, 2B and soon to enter Ph 3 and pre-sub.

This is the type of molecule, working in a type of team, and size of company (hence the resources they have to drive development), most GRLs in Oncology dream about! It is working on the next round of novel checkpoint inhibitors beyond PD-1, PD-L1 treatments.

The role is a proper ‘global strategy role’, so the US Regulatory Leaders are a separate role, and report to you for strategy, as do the European RLs, international majors RLs and full RA sub-team.

You will be supported by a senior leadership individual who has a superb energy, and is rounded in their approach, a real kind and interested manager, whom has the track record and understanding of governance and strategy to be able to leap frog your strategies developed hand in hand with clinical science (the main partner with Stats) to drive the programs and set the team up for success.

  • Global role, in a global program with how do I put it, ‘very promising data’
  • Superb LT to support you, with the hurdles in a collegiate and personal way
  • Overall, highly tipped pipeline, in a company where the bar is set high but the people are generally humble and focused, supportive and helpful
  • The GRL is not a combined US / GRL role, you get to focus on developing and shaping the global strategy with the regional plans
  • You can attend major agency meetings (post Covid) as you see fit!

The company are grading this role as Director, but if you are on the cusp, we would still like you to apply. The company will buyout stock plan, bonus, within reason, and have a set of policies in place to be able to manage digital hiring (from home), home working, and relocation (which can be next summer). The package is high end, and commensurate with the quality of the project / molecule.

In return, you will have already shown yourself in solid tumour or haemo, and have led or co-led submissions either in the USA, or Europe or both, and now want to work on a NME, and be in the GRL hot seat. If you are a GRL or GTRL already, and want a new molecule, then we would also be keen to hear from you, either way, ADV Talent will support  you through the hiring process, each sep of the way.

Statement on Covid and Location / Relocation

The company has digital hiring in place, including interviews and on-boarding, you will stay in place until the offices open. The offices are in New Jersey.

The company offer, post Covid, or post school year, a Cadillac relocation, to be timed to work with you, to the NJ or NJ/PA areas, which includes a house purchase relocation, a very generous settling in allowance, and expenses for running more than one house for a limited period of time, or temporary residence.

Please Respond To

To apply for this role, please press the red “Apply for position”, or contact me, Matt Greig, on 908-332-9157 and I will reply by return. I am able to speak with you weekdays as well as Saturday and Sunday AMs. All enquiries are taken in confidence!

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