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:
* 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.
QUALIFICATIONS:
* 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.
BENEFITS:
Salary of £95-105K plus benefits package.
APPLICATION:
Please quote job reference 108286 in all correspondence.
SENIORITY LEVEL:
Director
EMPLOYMENT TYPE:
Full-time
JOB FUNCTION:
Research and Science
INDUSTRIES:
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr