Associate Director / Director, Clinical Scientist

Valid8 Financial, Inc.; Philadelphia (Philadelphia County); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a dedicated Clinical Scientist to lead and support clinical trials in the innovative field of cell therapy. This role involves collaborating with cross-functional teams to ensure the successful execution of clinical studies, developing protocols, and contributing to regulatory submissions. The ideal candidate will possess a strong background in clinical drug development, T-cell biology, and regulatory guidelines, along with exceptional communication and problem-solving skills. Join a passionate team committed to advancing groundbreaking therapies that aim to improve patient outcomes and transform lives in the realm of autoimmune diseases.

Qualifications

• Minimum 7 years of experience in clinical drug development.
• Strong knowledge of ICH, GCP, and regulatory guidelines.

Responsibilities

• Support clinical science aspects of assigned Cell Therapy program.
• Lead development of recommendations on further development strategies.
• Contribute to documents such as IB, DSUR, and regulatory submissions.

Skills

Clinical Drug Development

T-cell Biology

Cell & Gene Therapy

Regulatory Guidelines (ICH, GCP)

Literature Reviews

Communication Skills

Problem-Solving Skills

Organizational Skills

Education

Bachelor of Science

Master's degree or PhD

Job description

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved.

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; review SAPs and TLF shells; participate in emerging clinical trial data evaluation and interpretation; ensure that assigned studies are conducted according to GCPs and Cabaletta’s SOPs; conduct literature searches and reviews, meta-analyses, and publishing data; oversee the review of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov (clinical trial registry and results database) and assist 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:

• Support the Medical Director or may serve as Clinical Lead in clinical science aspects of the assigned Cell Therapy program.
• Assists 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.
• Member of 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 for regulatory documents such as INDs/CTAs/ accelerated program/RMAT designations/pediatric study plans, and BLA/MAAs.
• 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.
• Provides 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.
• May attend Site Initiation Visits, to present the study design and key aspects of the protocol.
• Leads the compilation and interpretation of the data for and from safety review committees, collaborating closely with the Medical Director.

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
• 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
• Experience in the biotech industry or in a startup industrial setting is preferred.

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.