Naynesh Mistry at CK Science is currently recruiting for a Senior Study Director – (Protein Chemistry) to join a leading pharmaceutical and biopharmaceutical company based in Yorkshire on a permanent basis.
Responsibilities:
The Senior Study Director will manage complex customer programmes with multiple studies and/or have managerial responsibilities for other Study Directors. They will focus on development, coaching and key line management responsibilities
As a Senior Study Director you will:
- Ensure that the study is performed in accordance with the study protocol
- Ensure that the study is performed to the required scientific and regulatory standards
- In depth and up to date knowledge of UK/OECD GXP regulations as applicable, SD roles and responsibilities, organisation of multi-site studies
- Holds start-up and on-going study meetings
- To be aware at all times of study status and anticipate problems that may affect timing, quality etc taking appropriate action to resolve such problems
- Ensure that all study communication is documented and maintained and carried out to meet client requirements
- Demonstrates knowledge of client requirements and plans accordingly (timelines, critical deadlines etc)
- Provides client feedback to team
- Produces study protocols and reports to meet client and regulatory requirements
- In depth knowledge of relevant assays, able to advise internal/external clients on study designs
- Development, coaching and management of study directors
Qualifications and skills:
The successful candidate for this Senior Study Director role will have the following qualifications, skills and experiences:
- Degree in Life Science, BSc, MSc, Ph.D or equivalent
- Candidates are expected to have relevant experience (study directing, management of analytical teams or project management and other Study Directors) in a regulatory environment (GLP/GCP/GMP).
- In addition, experience of client management and technical expertise in a relevant scientific arena is required.
- Experience of client management and technical expertise in large molecules.
- Experience within industry
- A sound working knowledge of ‘Good Laboratory Practice’ and ‘Good Manufacturing Practice’ would be advantageous.
This opportunity may be of interest to individuals who have experience in or an interest in: Senior Study Manager, Principal Investigator, Principal Scientist, Lead Scientist, Senior Scientist, Senior Analytical Study Lead, Analytical Team Leader.
H
ow to apply:
For more information or to apply for this Senior Study Director role please contact Naynesh Mistry via email: nmistry@ckscience.co.uk or telephone: 0114 283 9956. Please quote reference SH24965 in all correspondence.
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