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Non-Clinical Director

Essex, , HertfordshirePermanent
Experience Dependent
Job Reference: J5635031
Updated On: 09/06/2021
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Biotechnology, Consultancy, Cell & Gene Therapy

Skills: Life Sciences - DMPK in vivo, Pharmacology - In Vivo, Toxicology - Pharma, Regulatory Affairs - EU, Regulatory Affairs - Manager / Director / Executive, Regulatory Affairs - Biologics, Regulatory Affairs - ATMPs

Job Information

Role Overview

We are currently looking for a Non-Clinical Director to join a leading Regulatory Consultancy specialising in ATMPs and Biological products . As the Non-Clinical Director your central focus will be to off Non-Clinical advice, strategic planning and study design to a range of clients developing Biological and Small molecule products.

You will be the subject matter expert for toxicology, safety pharmacology, mechanistic and primary pharmacology issues for small molecule, Biological and Advanced Therapy products.

My client is a leading bespoke Regulatory Consultancy with offices in London, Essex, Cambridge and Europe and this position would offer remote working. My client is keen not just to speak with Regulatory professionals but experienced Study Directors in the non-clinical space that can offer expert advice and guidance to clients.

Key Duties and Responsibilities

Your duties as the Non-Clinical Director will be varied however the key duties and responsibilities are as follows:

1. Be the Non-Clinical subject matter expert for toxicology, safety pharmacology, mechanistic and primary
pharmacology issues for small molecules, biologics and ATMPs

2. Provide leadership in scientific advice meetings at national agencies and EMA and provide expert EU non-clinical regulatory strategy support at all stages of development

3. Author a range of Regulatory Documentation including but not limited to IMPDs, INDs, IBs, Briefing Documents, Orphan Applications, PIPs as well as summaries and overviews for MAA, NDA and BLA

4. Act as client lead offering strong communication skills with the willingness to travel as required (COVID Dependent).

Role Requirements

To be successful in your application to this exciting opportunity as the Non-Clinical Director we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline plus extensive industry experience in a non-clinical setting where you have gained knowledge and experience of Study Design, Regulatory requirements and documentation writing.

2. Proven industry experience writing Regulatory Documentation including but not limited to Scientific Advice documents, IMPDs, INDs, MAA/BLA etc.

3. A working knowledge and practical experience working with in a range of Therapy areas with a range of molecules would be beneficial to your application.

Key Words: Non-Clinica | Pre-Clinical | Study Design | Study Manager | Study Director | Leader | Strategy | Consultant |Toxicology | Safety Pharmacology | In Vivo | Animal Studies | Animal Models | Regulatory Affairs
Georgia Walden
Your Recruitment ConsultantGeorgia WaldenGeorgia.walden@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.