Associate Regulatory Director ** NW Boston, Massachusetts ** Early Development ** Gain Global **
Expiry Date: 31-03-2022
Job Type: Full Time
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This is a rare opportunity to join a smaller company entering its growth phase, as it transitions from being a discovery company to a high potential drug development company, with their headline NMEs now entering Ph 1a/b. This will appeal to you if you want to work in an organization at the very beginning of this transition, knowing it is well-funded, led by big pharma oncology leadership (including the line manager) with their know-how, but still in its infancy – you will be here as one of the first few hires in regulatory, so you will help grow and shape not just the pipeline but also the company and culture, systems and process.
Why consider this role?
- Company has brought 4 NMEs into clinical phase 1 and has partnered some of these compounds with top 5 oncology powerhouses – there are multiple other NMEs and new targets translating through
- You want to be one of the early founding employees in a company where everyone gets stock options, the organization have around 120 employees right now
- You will be happy to attend their site in a semi hybrid model, which is based north of Boston, Massachusetts
- Reports directly to a Head of Regulatory, you will be one of their first hires in regulatory and will be part of the creation team, which helps bring the NMEs into clinic, identify adaptive or fast track / prime designation, orphan and eventually co-lead your NME into pivotal study and filing
- The role is global, my client would like it if you had expertise in US submissions or procedures such as INDs, BTDs, or PRIME, etc
- Truly innovative and first in class drug development platform which joins small peptides to chemical therapies, smaller than an ADC but in some ways offering much more flexibility, no identified immunogenicity and a better ADME profile potentially that ADCs, NCEs, and mAbs
- Company has several compounds coming into or in Ph 1, you will be part of a small team which builds the road, not just travels it, and be happy working on department initiatives, managing CROs and consultants and working in a smaller more nimble company
What this role is doing?
- You will provide both some strategy and operational coordination and execution of regulatory plans, coordinating , compiling, reviewing and submitting INDs, CTAs, ODDs, PIPs
- As the company is in clinical phase, clinical submissions and procedures is prioritized over MAAs
- You will help to prepare and support regulatory strategy, but this is not a pure strategy role, and between the CROs and consultants, the dossiers have to be compiled
- You will support health authority interactions, Scientific Advice, and manage responses to HA questions
- The role is though going to grow as the pipeline grows, and you will be mentored and developed by an ex oncology powerhouse line manager, who has worked in oncology and other TAs, is very down to earth, pragmatic, not a suffocating manager, who will hone your capabilities and grow your depth of knowledge and experience
Your Background & Skills
- Around 5 years or more in drug development regulatory affairs, backed up by a higher degree ideally, oncology is a plus
- Experience in developing tactical and strategy plans, moreover, preparing and submitting INDs, ideally or CTAs, preparing HA meetings brochures, PIPs, and ODD submissions
Ability to work in a company which is not a start-up, but is now changing into a clinical phase drug development company, so you will need to be adaptive, able to build processes as you go, and have a collaborative manner in working (some of your peers are very strong scientists and functional experts).
To apply for this role, please press the red “Apply for position” button, or contact me, Roland, for this role by email to email@example.com or if you would like more information on the role, on 908 348 6717. I will support you throughout the interview and on-boarding experience.
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