Clinical Scientist Post Approval Research (Director Level)
We are looking for a talented Clinical Scientist Post Approval Researcher at a Director Level. This an amazing opportunity to join a biotechnology company based in Oxford. The organisation is focused on improving patients' lives by addressing their unmet medical needs.
- Clearly articulate to internal stakeholders the data obtained in post-approval studies and how it can be applied to business and medical decisions.
- Coordinate closely with the Global Molecule Team to understand data gaps and needs within regions
- Analyze and present medical and clinical trial data to leadership
- Maintain a clear understanding of data gaps and how the proposed post-approval research strategy addresses respective needs
- Manage complex studies including the budget and make respective tradeoffs for Phase IV research
- Oversee post approval research studies to ensure the studies are proceeding in accordance with protocols established in planning and assist researchers as needed
- Provide expertise in leveraging emerging technologies (wearables, EMR, mobile technologies) to improve efficiency and gather real-time data to support post approval research
- Maintain expertise and understanding of documentation needed for data collection and analysis, regulatory requirements, polices and processes
- Deep understanding of the market landscape and medical communities' needs
- Develop and maintain relationships with external regulatory bodies and lead regulatory submissions process, in accordance with FDA and EMA guidelines
- Maintain a global mindset with ability to think in an integrated, holistic fashion
Skills and Requirements:
- Doctorate degree required.
- Clinical experience in H/O highly desired.
- Previous (> 5 years) medical affairs or clinical development experience in H/O highly desired.
- Deep experience with post marketing Phase IV research.
- Strong leadership, team building, negotiation and ability to execute a must.
- Ability to travel required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Terence Au at 02038618605 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.