US Tri-State ** Global Regulatory Leader **Lead highly promising MM asset out of P2 to filing! (Code USA 130221-1 )

Reference: MG130221A

Expiry Date: 12-07-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
United States

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Job Description

US Tri-State ** Global Regulatory Leader **Lead highly promising MM asset out of P2 to filing!

My client is a prestigious top 5 biopharmaceutical company with a stable of high value patient products, a large pipeline across multiple therapeutic areas, and an enviable reputation build over many decades.

We are looking for a self-starter, who wants to take the hotseat, as Global Regulatory Leader for a Ph 2 asset with highly promising existing data, in a role where you will lead RA strategy and filings, with oversight for the key regulatory milestones for a MM NME:-

  • This is a novel type of ligase modulator, with excellent early phase date in ORR of approx. 35-60% in different cohorts (based in data published end of last year)
  • It is a high priority asset and visible, also you can imagine the team will want to identify each and every possible way to speed the asset through development to global registrations
  • You will be an experienced Global Regulatory Lead currently, or an experienced US RA Liaison, with exposure to the EU framework, and want a new program with a decent probability of success based on current clinical data  
  • This is the strategy regulatory lead role for global, so you will be in the driving seat, to evolve their P2 strategy, finish the MTD/ RP2D studies and engage the health authorities for pivotal studies (you can elect to attend HA meetings in any region if you feel it would add value or provide the right support to your local liaisons)
  • You will be supported by an experienced Executive Director, who has led some rather well-known BLA/NDA filings in their time, who will help you develop your footprint, and bring you into the project team; the individual is super collegiate and has lots of EQ
  • The company has a Cadillac relocation, will postpone relocations until after Covid, and post-Covid they offer a 50% 50% in time split, as a standard home working policy post-Covid
  • This role is commutable post-Covid from PA, NYC, NJ, CT, north MD and DE
  • The hiring process will be run over MS Team.

You will be hungry to find a NME and project which can catapult your career. If I look at the role and who it reports to, you can see how my client values merit, as the hiring manager did this type of role for some time, before being promoted twice to their current level, based on their passion, filings, and approvals.

What I like about the role is really twofold: the asset and the team.

It is part of a hematology regulatory group with a run of successes in the last 15 years, and is seeking to push the boundaries of haemo treatment both in terms of treatment options and survivability. The GRL role at this company has a lot of visibility, is embedded in the project team, and works hand in hand with stats and clinical, under the guidance of the line manager, who tends to manage form behind or as a facilitator to help the team identify and evaluate new ideas and approaches. The individual has a good reputation for building their people up!

You will be responsible for further developing the inherited RA strategy, steering and aligning with the EU, US and China RLs and for leading the sub-teams for INDs and the NDA core dossier, HA briefing packs, major responses to HA queries, any potential request for any type of accelerated or adaptive pathway, and of course, the HA meetings, EOP2, Pre-Sub, Review, etc.

Package & Relocation (if required)

In return you will receive a high-end package, a strong incentive stock and performance plan, and a relocation which can be stop watched til safe to move. The relocation is very strong, for house sale and purchase costs, as well as for renting if needed. My client will buyout stock, pension differences as well as lost bonus from leaving your current company.

To Apply!

To apply for this new role, please contact us, asking for me, Roland on US 908-348-6717 or my colleague Matt, on 908-332-9157 or send us a full CV in complete confidence to roland@advtalent.com and I will reply by return.  ADV Talent operates a Global Data Protection policy and will not forward your details without your written consent.

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