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Non-Clinical Director

Employer
Hyper Recruitment Solutions
Location
Harlow
Salary
Dependent on Experience
Closing date
7 Jul 2021

Job Details

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-Clinical | Pre-Clinical | Study Design | Study Manager | Study Director | Leader | Strategy | Consultant | Toxicology | Safety Pharmacology | In Vivo | Animal Studies | Animal Models | Regulatory Affairs

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.

Company

Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.

Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.

Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.

We provide services across a broad range of industries including the following specialist sectors:

• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science

With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:


• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability 
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments


HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.

Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com


Or any of the social media routes below: 
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Company info
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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