Description
Medical degree (MBBS or equivalent) and have previously been engaged for a minimum of 3 (ideally 5) years medical practice within a UK hospital or general practice setting.* Must have training in ICH/GCP principles. Internal training will be required on both global and local policies.
* Required: 2 - 5 years experience in Phase 2 - 4 clinical development in the pharmaceutical industry and/or at a CRO, practical experience in clinical trial strategies, methods and processes.
* Previous leadership/management experience or training desirable for RMM Lead role
TECHNICAL SKILLS REQUIREMENTS
* Strong knowledge of clinical development, principles of ICH/GCP, and experience in the management and reporting of adverse events and SAEs
* Experience in regulatory audits preferred
* Thorough knowledge of local UK regulations applicable to clinical development including Ethics Committees' standards
* Practical knowledge of clinical trial strategies, methods and processes
Clinical trial expertise
* Expert in full drug development processes from phase I to IV
* Extensive medical knowledge and AE/SAE expertise
* Good relationship with wide net of KOLs in different therapeutic areas
* Thorough knowledge of the company direction, investigational product(s) and its development plan, the protocol, applicable SOPs, GCP, data privacy laws
* Demonstrated potential or ability to initiate and conduct clinical studies in industry, academic, or research clinic setting
* Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents
* Knowledge of the UK clinical trials environment, culture, patient populations, specific TA nuances/standard practices of medicine.
Medical skills and Scientific excellence
* Understanding of the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development