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.
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.
For more information or to apply for this Senior Study Director role please contact Naynesh Mistry via email: firstname.lastname@example.org or telephone: 0114 283 9956. Please quote reference SH24965 in all correspondence.
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