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# Job Title: Senior Clinical Scientist
# Location: Hybrid, Central London
# Salary: 95-105K
# Description:
CK Group are recruiting for a Senior Clinical Scientist to join an innovative biotechnology company with a large and diverse product pipeline. You will need to work from their central London offices on a hybrid basis.
RESPONSIBILITIES:
As Senior Clinical Scientist you will be responsible for the creation, review, and editing of high-quality scientific and regulatory documents, oversight of early phase Oncology trials and the scientific review and interpretation of clinical study data.
- Leading the design, development, writing and review of protocol synopses, protocols, and amendments, patient facing documentation, Clinical Study Reports and other key documents
- Ensuring protocols and all other regulatory documents are scientifically accurate (including QC), aligned with regulatory requirements, and meet the strategic objectives of the project
- Leading / Contributing to the creation of relevant sections of all key regulatory documents including Investigator Brochure, INDs, CTAs, IND/NDA Annual Reports, and Development Safety Update Reports, PIPs, and Regulatory authority submissions and responses
- Supporting the development of asset strategy, including development and approval of target product profiles and claims, input to trial designs and plans
- Contributing to external academic and commercial collaborations, ensuring that data is communicated effectively and fosters productive partnerships
As Senior Clinical Scientist you will require:
- An advanced degree in life science, pharmacy or medicine
- Extensive, industry-based experience of early phase clinical development for Oncology treatments
- An expert understanding of clinical research methodologies, regulatory guidelines (ICH, FDA, EMA) regulatory submissions (IND, NDA, CTD), and Good Clinical Practice (GCP)
- Experience of biostatistics and data analysis
- A proven track record in the development of, writing and delivery of study protocols, amendments and all the ancillary regulatory documents required to conduct and report global Phase 1 and 2 trials in oncology
- Ability to interpret and present complex data sets in a clear and concise manner
Salary of 95-105K plus benefits package
Apply:
Please quote job reference (phone number removed) in all correspondence.
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