Global Regulatory Leader ** Major NME with a WOW factor ** Solid Tumor ** High velocity role you join at Ph1B, a major $USD asset

Reference: MG280319A

Expiry Date: 30-11-2019

Categories Biotech, R & D, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Philadelphia County
United States

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Job Description

 

Global Regulatory Leader ** Major NME with a WOW factor ** Solid Tumor ** High velocity role you join at Ph1B, a major $USD asset

Location: PA, USA

This role is assigned to me, Matt Greig, you can contact me on US toll free 855.505.1382 or within Europe call +447918679405 - alternatively please send me a full CV to matt@advtalent.com and I will contact you by return. I do take calls on Saturday and Sunday AMs (US time), as well as normal office hours!    

You will consider yourself a standout person, with the type of influencing and motivational skills your regional liaisons or teams rally to, as we are seeking a superset Regulatory Strategist to lead a massive programme across 3 solid tumour types with multiple studies, combinations and biomarkers  - you will relish complexity and know how to steer agility in design with adaptive and accelerated regulatory pathways.

Why consider this role?

  • Join a programme at Phase 1B as the Global Regulatory Leader and Sub Team Leader which means you will lead US, EU, EM and China / Japan overall RA strategy?
  • Have you led now US BLAs or US NDAs in Solid Tumour, and now you want to be a GRL?
  • Do you feel like you were passed over for your next project and want to address this by joining a mega programme as a GRL?
  • This company allows GRLs to directly manage people (typically in Ph 2/3 when the workload peaks) which is rare in industry - so if you are an existing GRL and want to be a Senior or Group Director need to gain direct management experience, this is certainly one role to consider
  • Want to work in a upper level matrix, in a non-hierarchical structure where you spend time with the Global Head not just the Executive Director, and the design and strategy definition happens in a safe conversational space where innovation and smart risk-taking is applauded
  • Want to be in a company with the resources to initiate multiple studies in one go, in parallel not sequential, in a global project team with the best thinkers in clinical, diagnostics, stats and commercialization.

You will be someone who knows and has partnered with clinical, to help shape the clinical trials, and will be scientifically conversant and literate in solid tumour, either within the abdomen space, or lung, or breast.

The company is a significant player in the oncology field, and spending more as a % of R&D than most of our clients, and has had many successes already, so you will be joining a successful team, managed by an senior individual who did this role until 2 years ago themselves (with approvals), and under the guidance and mentoring of a luminary global head of oncology in regulatory affairs, who has delivered for other major I-O and personalized medicines innovators.

The role is based in PA / NJ area and are offering a Cadillac package and relocation, for the right person, from anywhere in the USA, or potentially Europe. The company will buy out stock plans for the right person, and have a track record of developing their people. The company is about to rapidly expand, so if you want an environment where your position can take off, then it’s time to update your CV!

 

To Apply! 

This role is assigned to me, Matt Greig, you can contact me on US toll free 855.505.1382 or within Europe call +447918679405 - alternatively please send me a full CV to matt@advtalent.com and I will contact you by return. I do take calls on Saturday and Sunday AMs (US time), as well as normal office hours!

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