Our Client is organising a Phase 1 clinical trial of its lead cancer vaccine. They require a CMO who will be the key advisor to the CEO and Clinical Project Manager to support oversight of the CRO to deliver the Phase 1 clinical trial for the candidate vaccine. The role holder will be a key link to the regulatory authorities and clinical investigators, representing the company as required.
The role holder will advise on the development, implementation and successful execution of clinical and medical operations as well as review and approve all clinical procedures, clinical protocols, quality and safety requirements. The role holder will contribute to clinical audit review. The role holder will assist and present clinical data at clinical advisory board meetings and contribute to other internal and external presentations or publications.
The company is seeking a senior individual with industry experience within Oncology, preferably with experience with immunotherapies or vaccines. This role will be on a consultative basis initially advising from a medical viewpoint on the direction of this and future trials and is expected to be 4-6 days/month.
The role requires strong pre-clinical and early clinical experience. Ability to build key relationships easily across all levels of the company is key. Prior experience working as a freelance CMO would be a benefit.