Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Reporting to the Vice President, Clinical Operations, the Clinical Project Manager (CPM) is responsible for the overall management and execution of operational activities involved in the planning, implementation, conduct and completion of clinical trials. This includes management of study deliverables, adherence to budget and timelines, negotiating vendor agreements, approving vendor and Investigator invoices and accruals, and ongoing risk mitigation. The CPM leads and engages with cross functional study teams and stakeholders (program management, site education and monitoring, clinical science, data management, biostatistics, medical writing, medical affairs, regulatory affairs, clinical accounting, and clinical QA) to ensure the project is completed on time, within budget, and with high quality.
· Manage and coordinate all aspects of assigned global clinical trials to ensure they are conducted in accordance with established protocols, Company standards (SOPs), ICH/GCP and applicable jurisdiction regulations.
· Identify and manage the identification, evaluation, and selection of external vendors (central lab, CROs, consultants/contractors, etc.) from RFP through budget/ contract negotiations and execution.
· Performs ongoing vendor management to ensure deliverables, high performance standards, and adherence to the contract or change order
· Oversees, manages and reports on project activities, including scope, schedule, budget and risk associated with each assigned project.
· Identifies and tracks key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
· Develops clinical trial timelines and operational budget, tracks the overall study critical path and manages/oversees all study activities to ensure on-time study delivery.
· Reports study performance and timelines to senior management
· Assists in the identification, selection and initiation of clinical sites
· Oversees the development of required study plans and execution of those plans related to site monitoring, safety management, data management and biostatistics
· Oversees development of CRFs and clinical and safety databases
· Plans, coordinates and conducts investigator meetings globally
· Plans, coordinates and conducts Data Safety Monitoring Board (DSMB) meetings
· With Medical Affairs, assesses trends in data including adverse events, protocol violations, etc.
· Coordinates and manages timely database freeze and database lock.
· Participates in data review meeting.
· Ensures eTMF maintenance in accordance with regulatory standards and requirements
· Assists the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents
· Assists Regulatory Affairs as necessary for IND/CTA filing and other necessary compliance requirements.
· Ensures that clinical operations milestones are prioritized and that team members remain on task to achieve business and departmental goals
· Leads clinical operations meetings with vendors, interdepartmental staff, and alliances.
Experience & Qualifications:
- BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent combination of education and experience
- Minimum 2 years of clinical trial/project management experience. Prior experience as a CRA or on-site is preferred, as well.
- Oncolytic virus, cell therapy, or immunotherapy experience is preferred.
- Ability to travel internationally or domestically up to 10-20% based on study demands
- Excellent working knowledge of GCP/ICH Guidelines
- Ability to work effectively independently or as part of a team, remotely or in-office
- Comfortable managing multiple projects and ability to adapt to changing priorities
- Effective written communication skills and computer skills are required
- Strong understanding of Clinical Development
- Self-starter and able to “wear many hats” while communicating with a cross-function team in a mid-sized biotech.
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.