Associate Director, Clinical Operations

1 day ago

Waltham MA United States Tscanrx Full time
Associate Director, Clinical Operations (AD30-1) LOCATION: Waltham, MA

Position Summary:

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 an Associate Director, Clinical Operations to oversee the execution of clinical in our solid tumor oncology program. 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.

Responsibilities:

  • Oversee the day-to-day internal and external clinical operations activities to support the solid tumor oncology program.
  • Manage external resources including consultants, CROs, central labs and other vendors to ensure study deliverables are met.
  • Lead the RFP and vendor evaluation process to identify and select new vendors.
  • Serve as the main point of contact with clinical sites to triage questions.
  • Contribute to the development of study documents including protocol amendments, study plans, ICFs, IBs, CRFs, etc.
  • Participate in data review with other core functions such as medical and data management.
  • Work with the finance team to track the study budget including reviewing and reconciling budget variances, tracking change orders, reviewing and approving invoices and forecasting future spend.
  • Develop and track project timelines and identify risks to the timelines and associated mitigation strategies.
  • Work with the CRO and internal stakeholders to respond to IRB questions.
  • Work with the internal supply chain group to ensure delivery of leukopaks and drug product to and from the sites to TScan’s internal GMP facility and forecast future drug needs.
  • Oversee site feasibility activities to identify new US and ex-US sites.
  • Ensure studies are executed in compliance with internal SOPs and following ICH, GCP and other relevant guidances.
  • Build and maintain effective relationships with clinical sites, including triaging day to day issues, presenting at SIVs, etc.
  • Manage CTM and/or CTA direct reports.

Requirements:

  • 8 -10 years of experience managing oncology clinical studies, preferably with 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
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