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Operations Manager, Translational Medicine

Philadelphia, PA

About the Position

The Translational Medicine Group supports the clinical development of Cabaletta’s genetically engineered T cell therapies treating autoimmune diseases. In this cutting-edge field of Immunotherapy, translational medicine research strives to identify key biologic mechanisms contributing to patient responses to CART and CAAR-T cell therapies. 

Reporting to the Director, Translational Medicine, we are seeking an experienced, motivated, detail-oriented, and highly skilled Operations Manager within our Translational Medicine team.  This role is designed to be a hybrid of in-person and remote work with schedules determined with the hiring manager.  Under supervision, the individual will support translational medicine initiatives and collaborations with key stake holders across internal clinical operations, clinical sites and research partners and will be responsible for clinical sample management activities. The candidate should be a highly motivated self-starter with well-established organizational skills who is excited to be a part of the biotechnology industry. 

Responsibilities Include

  • Work closely with the Director, Translational Medicine and Associate Director, Project Management on the management and handling of clinical samples, both internally and externally, including supporting the shipping and receiving of clinical samples.
  • Reconcile informed consent for use of clinical biospecimens to support translational scientists
  • Liaise with research scientists and clinical study teams to ensure appropriate kits and collection manuals are designed to support research sample collections
  • Coordinate timely shipments of clinical samples from central labs to testing labs/CROs
  • Review and author relevant sections of clinical study related documents
  • Assist in timely review of CRO research contracts and invoices through communication with legal and finance groups respectively
  • Enforce GLP-compliant and detailed record keeping protocols for clinical sample chain of custody (receipt, usage, etc.) within Cabaletta Bio
  • Facilitate discussion amongst CROs, clinical sites and clinical teams to resolve sample discrepancies
  • Support translations scientists in other related operational needs as project/priorities evolve
  • Manage multiple internal projects / workstreams simultaneously.

Required Qualifications

  • BS in a biological sciences or biomedical engineering related field with 5+ years of experience in clinical drug development, or equivalent combination of education and experience. MS with + 3 years of work or research experience preferred.
  • Proficiency reviewing and authoring clinical protocol associated documents is required
  • Experience with clinical sample handling and inventory management
  • Knowledge of requirements for bio specimen acquisition to support downstream analyses is necessary (i.e. flow cytometry, immunoassays, PCR, NGS)
  • Experience navigating relationships with multi-disciplinary teams is required
  • Highly organized, with the capacity to prioritize and provide consistent, timely responses working both collaboratively and independently
  • Strong communication skills required to interact effectively with internal and external stake holders, senior management, external CROs
  • Management of contract research organizations is preferred
  • Previous exposure to translational science strategies in the cell therapy field is advantageous
  • Strong team orientation and passion for continuous self-development
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
  • Previous experience with GLP/GCP & ICH regulations

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.