Job Description

Position Summary:

TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Senior Manager/Associate Director, Clinical Operations to support the execution our Phase 2 registrational study in AML, ALL and MDS . 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:

• Support the day-to-day internal and external clinical operations activities to support the execution of the Phase 2 registrational study in AML, ALL and MDS.
• 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 CRO and internal stakeholders to respond to IRB and EC 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, EMA, ICH-GCP and other relevant guidances.
• Build and maintain effective relationships with clinical sites, including triaging day to day issues, presenting at SIVs, etc.

Requirements:

• Bachelor’s degree required
• 8 -10 years of experience managing oncology clinical studies on the sponsor side; prior experience with hematologic cancers required
• Experience in cell therapy studies highly preferred
• 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 guidances
• Working knowledge of EMA regulations
• Excellent oral and written business communication skills
• Experience managing direct reports
• Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders

About TScan:

TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan’s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women’s Hospital and Harvard Medical School. TScan’s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today.

EEO Statement

TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.

Recruitment & Staffing Agencies

TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.

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