Turnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Turnstone’s innovative TIL therapy is based upon the identification, selection, and expansion of the most potent tumor-reactive T cells, known as Selected TILs, and is designed to overcome the limitations of first-generation bulk TILs that have demonstrated objective responses only in limited tumor types. Turnstone’s most advanced program, TIDAL-01, is currently being evaluated in two Phase 1 studies in patients with melanoma, breast cancer and colorectal cancer, and the Company is also actively advancing its preclinical pipeline programs including TIDAL-02, its next Selected TIL program, and its TIDAL-01 and viral immunotherapy combination program.
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.
Job Summary:
The Sr. Clinical Trial Manager (CTM) manages the execution of clinical trials, including vendors (e.g., Clinical Research Organization) and study sites related issues, with supervision from the Director, Clinical Operations, of which this position will report into. This position works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all Turnstone functional areas and global office sites is essential. He/She develops, manages, and coordinates all clinical trial activities for their studies including managing Clinical Research Organizations (CROs), vendors and internal team members. The Sr CTM develops and applies best practices in the development, initiation, planning, execution, control and closing of projects. He/She is a proficient communicator and effective influencer who builds and maintains strong relationships internally and externally. All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures.
Job Responsibilities:
• Responsibilities include supporting the planning, execution, and interpretation of clinical trials and ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registrations.
• Manage all operational aspects of assigned clinical trial(s)Support the selection of vendors/CROs and provide effective ongoing management to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol. Independently manages less complex studies
• Monitor and track clinical trial progress and provide status update to stakeholders and at project team meetings to Sr Management as needed.
• Manage or support the Management of study contracting, budget, forecasting, accruals, and payment process for all clinical trial vendors including investigational sites
• Oversee all aspects of data cleaning and facilitate data locks, including oversight of clinical sites, CRO, vendors and collaboration with data management/statistics teams
• Drafts and coordinate review of relevant documents including protocols, informed consents, monitoring plans, with little supervision.
• Must be able to participate in cross-functional strategic initiatives under limited supervision. • Proactively identify potential issues/risks and recommends/implement solutions. Facilitate and SMT for assigned projects Prepare and/or present written and oral presentations regarding clinical trial progress/results internally and externally.
• Participate in clinical development initiatives such as clinical standard operating procedures, eTMF, etc.
• Coach members of a work team and ensures adherence to established guidelines
Technical skills and experience:
The ideal candidate should have a BA, BS in biological degree or degree in nursing, pharmacy, medical technology or equivalent mix of education, certifications, and experience. Minimum of 9 years of clinical trial management experience, at least 5 of which are as a Clinical Trial Manager for clinical development studies at a pharmaceutical/biotech organization or a combination of CRO and pharmaceutical/biotech, excluding OTC drugs
• Thorough understanding of FDA, ICH and GCP guidelines • Proven track record showing clear proficiency in clinical trial management skills
• Proven complex problem-solving skills collaboratively and independently
• Solid vendor management experience, e.g., CRO, laboratory, and clinical supply logistics
• Broad understanding of clinical operations related to pharmaceutical drug development process
• Detailed understanding of all aspects of oncology clinical protocol design and implementation & overall drug development
• Ability to effectively interface with personnel at clinical sites
• Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
• Excellent interpersonal, verbal, and written communication skills
• Ability and willingness to travel internationally and domestically
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.