POSITION DESCRIPTION: Director, Clinical Trial Operations
REPORTS TO: President, Spine/Disc Division
CATEGORY: Full-Time Exempt
Biorestorative Therapies (BRT) develops innovative biologics, primarily involving adult stem cells. The lead therapeutic product, BRTX-100, is an autologous cell therapy for the non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease and is intended for patients whose pain has not been alleviated by non-invasive procedures and potentially face the prospect of surgery. BRTX-100 is injected into the damaged disc in an outpatient procedure. BRT is in the process of establishing its own manufacturing facility for the production of BRTX-100 for its upcoming clinical trials, which are expected to start in early 2017.
The Director, Clinical Trial Operations will be a hands-on leader responsible for coordinating clinical trial activities and providing support for submission of documents to regulatory agencies. This position will manage all clinical aspects of clinical studies, including assessing operational feasibility and recommending study execution plans; developing and managing comprehensive study timelines and metrics; participating in the selection and management/oversight of external vendors/CROs while developing vendor specifications; reviewing vendor reports, budgets and metrics; preparing and presenting project debriefings as required; planning, executing, and leading study-specific meetings; and participating in site-monitoring visits. The role is also responsible for site selection, qualification and start-up, including negotiation of budgets and contracts.
- Manage clinical trials including investigator selection and analysis of potential patient recruitment. Closely track enrollment, preparation of trial-related documentation and interactions with clinical sites to ensure successful outcomes.
- Develop clinical trial protocols, investigator brochures, informed consent forms, and other documents required to conduct clinical trials. Develop and maintain clinical SOPs related to GCP activities, following these SOPs in the monitoring of clinical trials.
- Provide study-specific training and leadership to clinical research staff, including CROs, CRAs, sites, and other contract personnel.
- Work with other clinical operations personnel and vendors to develop eCRFs, conduct test runs, develop edit checks, ensure that appropriate data is being entered, and track queries during a study and assist with timely resolution.
- Maintain project files including all regulatory documents, including IRB and ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochures, protocols, case report forms instructions, consent documents, clinical trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence, schedules of payment, and all other study-related documents.
- Participate in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. Develop and manage the study budget and maintain it within financial goals. Review and approve clinical invoices against the approved budget.
- Oversee patient recruitment strategies to ensure efficient enrollment into clinical trials
- Have extensive knowledge of the pharmaceutical/biotech industry and FDA IND, ICH, and GxP regulations. Maintain active involvement in biotechnology and clinical affairs organizations to ensure up-to-date knowledge of current and future industry trends.
- Assist with regulatory filings, including the drafting, editing and preparation of routine correspondence and sections of INDs, BLAs, annual reports, amendments, supplements and other regulatory submissions.
- Attract, train, develop and mentor the very highest caliber of clinical employees. Develop staffing requirements and assume responsibility for planning and recruiting.
Minimum of five years of clinical trials experience in the pharmaceutical, biotech or CRO industries, with a minimum of two years of trial management experience
- Requires an undergraduate degree, preferably in the life sciences, engineering or related field, and an advanced degree would be advantageous
- Experience within smaller, entrepreneurial clinical stage, drug development company would be preferred
- Strong understanding of GCPs, ICH and knowledge of FDA IND regulations
- Independent, self-driven
- Strong interpersonal skills, ability to communicate clearly and influence staff at all levels and adept with project management
To apply for this position, please send a cover letter and CV to email@example.com.