Joshua Leggett is currently partnered with a niche, blue-ocean, clinical-stage biotech based on the East Coast that are in the process of developing an innovative AI technology that will help identify the next wave of medicines across the Oncology & Neurology sectors.
They are currently searching for a Clinical Operations Director who will be responsible for all operational aspects of assigned global clinical research activities and to give close oversight to the external vendors and CROS.
The appointed candidate will also be responsible for appropriate execution and oversight of clinical operational development for several. Accountable for all activities associated, directly or indirectly with trial execution and clinical development, reporting and submission activities of the compound, as appropriate.
- Set-up and management of timelines (update, revision as when needed in alignment with overall trial and project timelines
- Oversight on trial key deliverables/milestones
- Keep budget within Service Providers current, provide oversight/ updates to VP of Clinical Operations/CFO and keep track on performance, percentage of completion, obtain regular financial update reports
- Responsible for all clinical documents such as protocols, ICFs, Investigator Brochures, clinical reports etc
- Responsible for the management and oversight of the CRO & external vendors
- Coordinate and drive clinical development programs across the whole of the US
- Prepare and manage the annual clinical operations
- Regularly assess quality and timeliness of deliverables as outlined in Sponsor Oversight Plan, and initiate/implement and supervise of remediation/contingency plans when needed
- Proactively drive and oversee trial conduct
- Be key contact person and insure close interaction, virtual and face-to-face, with Service Providers
- Ensure close interaction with cross-functional experts involved in the clinical study
- 8+ years’ professional experience in clinical research in Pharmaceutical, Biotechnology or CRO with at least 6+ years’ proven expertise in all aspects of clinical trial management
- Must have a degree in life science
- Deep understanding Neurology or Oncology
- Experience managing a team of Clinical Operations staff with a demonstrated track record of effective clinical management.
- Experience managing a budget and other concurrent multiple project
If this job does not quite interest you, we may have other opportunities that are more relevant. So please visit our website – www.alsolutions.co.uk or reach out via:
Tel - +44 (0) 203 778 0909
Email – firstname.lastname@example.org