LOCATION: Waltham, MA
TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Director, Clinical Operations to oversee the initiation and execution of clinical studies to support our oncology programs. The ideal candidate should have relevant experience in oncology clinical studies, ideally with a cell therapy product, and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
- Lead the RFP process to evaluate and select CROs and other external vendors
- Participate in IND enabling activities including development of clinical documents such as the clinical protocol, ICF and IB
- Develop, maintain, and report on study budgets, including forecasting study costs and collaborating with finance to track monthly accruals and variances
- Manage internal and external resources to ensure trials are initiated and executed per the expected timelines and budget
- Ensure studies are executed in compliance with internal SOPs and following ICH, GCP and other relevant guidelines
- Work with internal supply chain and manufacturing groups to forecast drug supply
- Manage delivery of leukopaks and drug product to and from clinical sites and TScan’s internal GMP manufacturing facility
- Manage external resources including consultants, CROs, central lab and other vendors to ensure study deliverables are met
- Oversee the development and compliance to study level operational plans (e.g. Quality plan, CRO Oversight Plan, etc.)
- Track and report study metrics to ensure key stakeholders have current information
- Develop and implement recruitment strategies to ensure efficient identification of prospectively selected patient populations
- Build and maintain effective relationships with clinical sites, including triaging day to day issues, presenting at safety meetings/SIVs, etc.
- PhD with 8 -10+ years, OR BS/MS with 15+ years of experience managing oncology clinical studies, including experience in cell therapy studies
- Excellent communication skills and ability to work in a flexible, matrix environment
- Knowledge of drug discovery and development program management from Phase 1 – registrational studies
- Advanced working knowledge of all relevant guidelines, including ICH, GCP, and other relevant FDA guidance’s
- Excellent oral and written business communication skills
- Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders
TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan’s discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.