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Medical Director/VP Clinical Operations
We are looking for a dynamic, experienced Medical Director/VP Clinical Operations to join our team. The candidate will be reporting to the Chief Medical Officer.
We are looking for someone who has moved assets through the development process, specifically with experience in late phase development. Prior exposure to the global regulatory authorities and working with external CROs and relevant clinicians across multiple geographies will be key to success in the role.
At a personal level, you must be comfortable operating effectively in a small, dynamic, collaborative, and innovative environment, being able to juggle both strategic tasks and being able to “roll up the
sleeves” and to get into the detail, as required. You must possess the energy, passion, and ambition to make a difference in an exciting biotech organization.
This is a unique opportunity to be a contributor to the success of a well-regarded, well financed and well positioned late-stage biotech company.
The Medical Director will help build and head a small team (e.g., Clinical Project Managers and Clinical Research Associates), and will play an important role driving progress and providing leadership to the Clinical team.
Clinical Project Manager
As first priority, the clinical project manager will lead, define, manage and develop the correlate of protection pilot study. Among this, will give input to the scientific rationale, practical conduct, as well as lead the way for MinervaX to reach a decision as regards the design of the phase III study with the MinervaX GBS vaccine in collaboration with the remaining MinervaX team and the CEO. Moreover, the clinical project manager will contribute to the other clinical studies ongoing at MinervaX both with clinical, scientific and regulatory expertise.
Analytical Quality Director
MinervaX is a growing company now entering into phase II clinical trials. MinervaX is establishing a development laboratory staffed by scientist and technicians who will be developing, qualifying and executing analytical methods for analysis of vaccine responses in samples from clinical trials and help develop biological analytical assay for manufacturing quality control. The lab will not initially be running a GLP environment but will implement the basic principles.
Clinical Trial Assistant
The CTA is an essential position within both the Clinical Operations, Quality Assurance and Regulatory Affairs area. The CTA will be responsible for supporting projects carrying out a broad variety of tasks in collaboration with relevant Minervax team members depending on the tasks.