Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, and myasthenia gravis are now recruiting.

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Associate Director/Director, Clinical Scientist (Remote)

About the Position

The Associate Director / Director, Clinical Scientist will collaborate with cross-functional teams (Clinical, Regulatory, Medical Writing, Translational Sciences, CMC, etc.) on writing clinical study synopses and protocols, Investigator Brochures, and clinical study reports; participating in emerging clinical trial data evaluation and interpretation; ensuring that assigned studies are conducted according to GCPs and Cabaletta’s SOPs; interacting with health authorities such as the FDA related to clinical trials, reviewing SAPs and TLF shells; conducting literature searches; overseeing the review of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov (clinical trial registry and results database) and assisting in preparation of IND/ BLA filing and accelerated/pediatric programs packages. The span of responsibilities is broad and will support several clinical programs depending on their size and complexity. The Clinical Scientist will liaise with various vendors and study investigators at participating sites.

Responsibilities Include

  • Collaborate with the Medical Director or serve as Clinical Lead in clinical science aspects of the assigned Cell Therapy program.
  • Collaborate with the Medical Director for clinical input to the clinical development plan (CDP) at all stages of the program.
  • Leads (or supports) development of recommendations on further development strategies to internal committees.
  • Participate in the cross-functional clinical trial team for assigned studies.
  • Participate in review of clinical and scientific data and developing product knowledge to understand and communicate the relevant information.
  • Participate in development, maintenance, and review of clinical study documents (e.g., protocols and protocol amendment(s), informed consent documents, case report forms) and other relevant strategic documents.
  • Support activities related to the start-up and execution of new clinical trials.
  • Contribute relevant clinical sections to documents such as the IB, DSUR, CSRs and regulatory documents such as INDs, CTAs, accelerated program, RMAT designations, pediatric study plans, BLAs, and MAAs.
  • Be responsible for clinical data review and drafting reports and presentations on the various findings of the clinical research, including abstracts, posters, publications.
  • Provide support with the activities related to the execution, monitoring, and reporting of clinical trials.
  • Provide scientific/medical mentorship (or coordinates) to the study team, including the CRO team.
  • Perform regular review of clinical data to ensure that the study is conducted in accordance with the protocol, safety procedures are followed, and efficiency is maintained.
  • Assist with safety review procedures: tracking of safety events, review of new SAEs, and composing/editing adverse event narratives.
  • Assist with managing vendor activities as needed.
  • In collaboration with the Medical Director, identify clinical sites that will participate in trials. Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
  • Attend Site Initiation Visits to present the study design and key aspects of the protocol, as needed.
  • Lead the compilation and interpretation of the data for safety review committees, collaborating closely with the Medical Director.

Required Qualifications

  • Bachelor of Science degree from an accredited educational institution.
  • Master's degree or PhD, PharmD/RN or the equivalent degree preferred.
  • Minimum 7 years of experience in clinical drug development within a pharmaceutical/biotech or academic environment.
  • Experience in the biotech industry or in a startup industry setting is preferred.
  • Strong knowledge of ICH, GCP, and other relevant regulatory guidelines.
  • Solid understanding of T-cell biology and cell & gene therapy.
  • Prior experience in cell therapy in pharma/biotech is a plus.
  • Experience in writing clinical protocols and performing and summarizing relevant literature reviews.
  • Strong communication and interpersonal skills.
  • Engaged, hands-on, and goal-oriented mentality in a highly dynamic work environment.
  • Ability to flexibly contribute simultaneously to multiple facets of drug development.
  • Demonstrated ability to learn new therapeutic areas and technologies.
  • Self-motivated, innovative, and critical thinker with strong commitment to follow up on action items.
  • Strong organizational, analytical, and problem-solving skills.
  • Thrives in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs.
  • Strong team orientation and passion for continuous self-development.


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How to Apply

Please click the link at the bottom of the posting to submit an application.

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.