Join Us

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors, ovarian cancer, NSCLC, and cholangiocarcinoma. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. 

We are headquartered in Cambridge, Massachusetts with a clinical manufacturing facility in Rockville, MD. This role will be based in Cambridge, MA.

As the Associate Director, Data Management (AD, DM) and first hire in the Clinical Data Management (CDM) group. Reporting to the VP, Clinical Development Operations you will ensure the quality for all Data Management (DM) deliverables. You will be looked to as the Data Management SME and responsible for setting the group strategy, standards, and growth plans as the team progresses into later stage development. 

Responsibilities:

• Strategic build out of the Data Management sub-function within Clinical Development
• Develop and implement data management standard working practices for regulatory inspections and or submissions
• Oversee the planning and management of external Data Management, and associated vendors across all clinical trials
• Responsible for  data transfer specifications, imports, and data integrity processes
• Ensure achievement of major Data Management deliverables in collaboration with other TCR2 departments including Clinical Operations, Clinical Safety and Pharmacovigilance, Translational Sciences, and Statistics
• Represent Data Management function on the Clinical Sub-team ensuring aligned expectations between the CRO and TCR2 for all data related deliverables, especially to support essential decisions and regulatory submissions
• Represent function in external professional projects and organizations such as SCDM, CDISC, DIA to identify industry best practice and increase the visibility of TCR2
• Provide input to functional governance with TCR2 strategic suppliers and vendor partners
• Participate in review of budgets/invoices relating to Data Management activities

Requirements:

• BS degree in analytical or health-related field
• 8+ years data management experience in the pharmaceutical industry. Prior management experience preferred 
• Experience managing vendor relationships and alliance partnerships
• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Experience with budget planning
• Prior experiences with inspection readiness, regulatory submission and strong CRO oversight.
• Excellent organizational skills, highly collaborative & supportive, attention to detail, communication, time management, and flexible attitude with respect to work assignment
• Proficient in multiple EDC platforms, related processes, and data visualization/graph tools (i.e.: Power BI, Tableau, SAS VA, GraphPad, etc.)
• Working knowledge of SAS, SQL, database design and database concepts
• Strong knowledge of CDISC standards (CDASH/SDTM)
• Understanding of coding (MedDRA, WHO drug dictionaries)
• Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.
• Self-starter and must function well under minimal supervision

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage immunotherapy company pioneering the development of novel T cell therapies. Our two lead cell product candidates are being studied in Phase 1/2 trials: TC-210 and TC-510 for solid tumors. Our research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomes. We are headquartered in Cambridge, Massachusetts and have a clinical manufacturing facility located in Rockville, MD. This role is located at 10 Wilson Rd in Cambridge. 

The TCR2 team is expanding, and we are hiring a Manager/Sr Manager to join our team to help coordinate and manage later stage lentiviral vector characterization and manufacturing efforts to support our growing pipeline. You will report to the department head and work closely with cross-functional teams including analytical development, manufacturing, quality, and regulatory departments during execution as required.

This role is a unique opportunity for you to advance your career development, actively working with a close team in a fast-paced and highly collaborative environment.

Responsibilities: 

• Lead coordination, documentation, and execution of end-to-end drug substance process characterization activities.
• Complete drafting and review of documentation to support eventual drug substance process qualification activities.
• Utilize project management and communication skills to help coordinate project plans and ensure successful execution of activities.
• Provide support to manufacturing investigations and regulatory filings as required within ongoing manufacturing activities.
• Provide updates on project status and deliverables to CMC and cross-functional teams as required.

Requirements: 

• BS or MS in chemical engineering, biochemical engineering, or related discipline and at least 5 years of industry experience.
• Technical experience with vector development and/or biologics manufacturing is required.
• Solid foundational knowledge of GMP manufacturing principles and experience working with external CMO/CTOs is preferred.
• Knowledge of process validation principles, including process characterization design and execution through performance qualification preferred.
• Familiarity with authoring documentation to support quality investigations as well as regulatory submissions is preferred.
• Outstanding critical thinking and organizational skills, leadership, and attention to detail. 
• Team-based candidate interested in a fast-paced, exciting, start-up environment. 

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage immunotherapy company pioneering the development of novel T cell therapies. Our two lead cell product candidates are being studied in Phase 1/2 trials: TC-210 for solid tumors and TC-510 for hematological malignancies. Our research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomes.

We are headquartered in Cambridge, Massachusetts and are building an internal manufacturing facility in Rockville, MD. This role is based in Cambridge, Massachusetts.

We are looking for a Quality Control Associate to work with our critical external testing laboratory partners and drive consistent, flawless execution of analytical testing associated with our autologous cell therapies. You will report to the Manager of External Quality Control and collaborate closely with our Quality Assurance, Manufacturing, and Supply Chain teams on clinical pipeline programs to help prepare the company for Phase 2-3/Pivotal trials and beyond. You will have the opportunity to work on leading edge technology while gaining valuable operational and partnership management skills. This position is also a great opportunity to have a direct impact on patients. If you thrive in a highly collaborative, fast-paced environment, are looking for a role where you’re given ownership and accountability to get results and make an impact, we want to hear from you.

Responsibilities:

• Review and evaluate test data, COA/COCs, and other test information to support the release of drug product for clinical use
• Monitor, analyze, trend, review and report test results.
• Support investigation and resolution of issues causing out-of-specification or out-of-trend results
• Participate in improvements to analytical testing strategy.
• Take an active role in the oversight and continuous improvement of partner company QC operations, particularly analytical testing

Requirements:

• Bachelors or Masters degree in Biochemistry, Micro/Molecular Biology, or related field.
• Minimum of 2 years experience in QC or Analytical Development role in a biotech or biologics operation
• Proficiency in GDP, and experience in analytical method data review and verification.
• Experience in various analytical techniques commonly used for cell and gene therapy testing, including flow cytometry, ELISAs, qPCR/ddPCR, and cell-based assays. 
• Experience with transfer, qualification, and validation of methods preferred.
• Technical writing skills, specifically with effective protocol.
• Excellent communication and collaboration skills required.
• Possess a flexible yet pragmatic approach to problem solving.
• At home in a results-driven, highly accountable collaborative environment where you can make a clear impact.

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

We are headquartered in Cambridge, Massachusetts and this role will be based in Cambridge.

We are looking for a Clinical Biomarker Scientist to coordinate interactions between project teams, assay specialists, CRO’s, Clinical Laboratories, and internal research efforts. You will report to our Senior Director of Translational Sciences and work closely with Translational Sciences and Clinical to interpret biomarker results in the context of TCR² clinical studies.

The ideal candidate will have demonstrated excellence in communicating and leading within a team-oriented & matrixed organization, multitasking/prioritizing within multiple projects, and leveraging information from a variety of sources to deliver quality biomarker data and insightful interpretation of the results. By ensuring a timely delivery of internally or externally generated biomarker data for analysis, the Clinical Biomarker Scientist will have a significant impact on understanding the mechanism of action of TRuC T cells as a potential cancer therapeutic and further our clinical development goals.

Responsibilities:

• Manage clinical pathology laboratory vendor and interpret immunohistochemistry/ immunofluorescence results.
• Work with bioanalytical vendors in assay development and patient testing for blood-based biomarkers such as cytokines and pharmacokinetics.
• Develop, maintain and adhere to SOPs in the TCR² quality management system, as required.
• Provide internal QC review of incoming data
• Analyze, interpret and present biomarker data to translational and clinical teams
• Assist in the preparation of data packages for publication and internal/external presentation
• Participate in preparing patient dashboards

Requirements:

• Degree in life science with a strong preference of industry experience in immunology and/or oncology clinical development.
• Typically, Bachelor’s degree with 3 – 5 years of experience or PhD in a scientific discipline with 0-2 years relevant experience; candidates with 6 – 8 years of commensurate experience will also be considered.
• Experience managing internal and/or external clinical pathology workflows and vendors is a requirement.
• Experience developing and maintaining an internal data management strategy.
• Laboratory information management system and/or sample management system experience.
• Experience in data analysis with software tools such as Excel and GraphPad Prism
• Proven ability to effectively work within matrixed teams made up of research, technical, and clinical colleagues. 
• Demonstrated ability to manage and contribute effectively to multiple projects at once.
• Ability to deliver on key milestones within defined timelines.