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PK Clinical Study Director

Employer
Hyper Recruitment Solutions
Location
West Yorkshire
Salary
Competitive
Closing date
21 Dec 2020

Job Details

We are currently looking for a PK Clinical Study Manager to join a leading Pharmaceutical company based in the Yorkshire area. As the PK Clinical Study Manger you will be responsible for the management of all of the company's Pharmacokinetic (PK) studies at Clinical Trial. You will use your years of experience and knowledge to be the internal PK expert on all R&D and Clinical projects to support the business needs.

This opportunity offers remote and flexible working so would not necessarily require relocation to the area.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the PK Clinical Study Manager will be varied however the key duties and responsibilities are as follows:

1. Study Directing - Manage all interactions with CROs from selection to Study and Protocol design to site visits and audits. You will also manage budgets and review clinical trial data.

2. Pharmacokinetics - Design studies for demonstrating bioequivalence and conduct model dependent and model independent analysis of drug release data. You will work cross functionally to support R&D programme development and will use your knowledge of Clinical PK studies to support the Regulatory team with strategic and timeline planning.

3. Regulatory - Support the development and review of clinical reports for MAAs and NDAs as well as ensure the GCP and ICH guidelines are maintained both internally and by CRO partners.

4. You will provide significant contribution to the R&D teams and key internal stake holders and will have to opportunity to be involved in developing business strategy.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences discipline (Chemistry, Pharmacology, Pharmacokinetics, Drug Development etc.) in addition to extensive experience in the field of Pharmacokinetics.

2. Proven industry experience of study design for PK Studies as well as Study Management for clinical studies. This include statistical methodologies for clinical science.

3. Ability to work on a variety of projects concurrently and communicate effectively with internal stakeholders and external collaborators.


Key Words: Pharmacokinetics | PK | Study Director | Study Management | CRO | Clinical | Clinical Trials | Bioequivalence | R&D | Regulatory | Subject Matter Expert | Pharmaceutical


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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