Gilbert Meher is currently exclusively partnered with an innovative biotechnology company who are using machine learning to make breakthroughs in disease diagnosis and management. Recent research success and fundraising has enabled them to transition to the commercial diagnostics space, and as a result they are seeking a Director of Clinical Operations.
My client are seeking a driven individual with a proven track-record leading large scale clinical trials in a biotechnology environment. The successful candidate will be responsible for the successful design and execution of clinical trials from concept through publication, working towards the launch of a pioneering cancer screening platform.
- Oversee clinical trials throughout design, protocol finalization and study execution.
- Manage operational plans and timelines, driving for on-time enrolment and study completion including the implementation of global performance metrics reporting systems.
- Work directly with senior management to develop project timelines, study budgets and report periodically to ensure the on-time completion of clinical program.
- Manage Contract Research Organisation and other vendor relationship and contracts.
- Oversee data collection, database construction and lead the auditing of data where appropriate to ensure continued data integrity.
- Ensure compliance with regulatory requirements including the implementation of SOPs in line with GCP, FDA.
- Cross-functional collaboration with assay development team to assist on product development where needed.
- Manage and oversee site training and educational interventions to ensure continued compliance with study protocols.
- >10 years’ clinical trial experience in biotechnology or diagnostics industry, with specific exposure to risk assessment and contingency planning. Diagnostics (IVD) a strong preference.
- Strong leadership experience, with a drive to implement change in a growing start-up environment.
- Proven knowledge of GCP, ICH and other US/international clinical regulatory requirements.
- A proven track-record of successfully implementing change and improving efficiencies.
- Clinical experience in Oncology a strong preference.
- Experienced in data management and knowledge of statistical principles and the application to clinical trials.
The position is to be based in San Francisco, California and will support relocation. If you are interested please apply directly.
Whilst we may not be able to respond personally to each applicant, we appreciate the time you have taken to consider and apply for a new role with us. If you have not heard from us within 4 weeks, then on this occasion your application has not been successful.