Associate Director, Clinical Science
3 weeks ago
Position: Associate Director, Clinical Science
Location: Cambridge, UK
Hybid model: x2 days p/w on-site
George Higginson is currently searching for an experienced Clinical Scientist, to join a clinical-stage Biotech, with a pipeline of over 7 clinical trials, covering Ph. II and Ph. III.
Partnering with an up-and-coming clinical-stage Biotech, developing a ground-breaking nanobody for Inflammatory Diseases, for this pivotal role, you will provide both scientific and clinical development support for one of their products, approaching a BLA Submission.
Main Responsibilities:
- Assist in protocol development in general and be fully responsible for specific sections of the protocol.
- Provide input and participate in writing of protocol amendments as needed.
- Provide input for CRF design.
- Provide guidelines for project specific and clinically relevant laboratory parameters.
- Provide input and review of SDV plans based on protocol specifications.
- Participate in the management of studies and provide training and science input to operation colleagues and study site staff.
- Support feasibility activities with operational colleagues
- Participate in the ongoing review of study data including reconciliation across databases and query generation.
- Participate in the writing of final study reports.
- Participate in NDA documentation and preparation of materials for use in presentation.
Experience:
- Master's degree in science and/or PhD (preferred).
- Over 5 years of experience in as a Clinical Scientist in either the Pharmaceutical or Biotech industry.
- Experience in designing and conducting large Phase II or Phase III clinical trials is a requirement.
- Experience working in drug development of large Phase II or Phase III/ IIIb.
- Experience with either Dermatology or Rheumatology (or both) would be advantageous.
- Team player, ambitious and can align with companies vision and values.
- Happy to be on-site x2 days p/w.
This is an exceptional opportunity for an experienced Clinical Scientist to join a blue-ocean clinical-stage Biotech, verging on the edge of commercialisation.
Apply above to learn more
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