Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.
Our recent successes are driving significant growth. As such. we are looking to recruit a Clinical Scientist to join our Clinical Development Studies team. Within this role, you will have responsibility (in collaboration and with support of a medical lead) for shaping and realising the clinical development plan for specific projects, with direct impact on the success of the development, associated timelines and approvability.
Within this role, you will:
Conduct literature research
Work with Key Opinion Leader's (KOL's)
Create Protocols, clinical development plans, monitoring plans and investigational brochures, in support of product development
Manage Data Safety Monitoring Board (DSMB)
Play an active part in the Clinical Development Sub-Team
To succeed, you will have:
Significant experience in clinical science, specifically within oncology.
Experience in the area of haematological cancers and immune-oncology is highly preferred.
Experience in working with paediatric oncological studies preferred.
Experience in organising advisory boards, working with DMC (DSMB)
Experience in preparing submissions to FDA, EMA
Excellent levels of innovative thinking and drive to perform ‘outside the box’ whilst conforming to the existing guidelines and regulations are essential for the role
Significant experience in leading and supporting global clinical development programmes Phase I-III, with demonstrated experience in working with KOL’s, regulatory agencies (FDA, PMDA, EMA)
Your personal attributes will include:
Very good communication skills
Ability to work in an internal cross-functional team
Experience of working externally with KOL’s, investigators and company’s vendors