Director, Clinical Scientist

Cabaletta Bio Inc

Philadelphia, PA

JOB DETAILS
SKILLS
Adjudication, Analysis Skills, Autoimmune Disease, Brochures, Clinical Data, Clinical Research, Clinical Study Publications, Clinical Trial, Conferences, Cross-Functional, Data Quality, Drug Development, Financial Trend Analysis, Gene Therapy, Identify Issues, Informed Consent, Mentoring, Patient Safety, Pharmacovigilance, Presentation/Verbal Skills, Regulations, Regulatory Reports, Regulatory Submissions, Safety Standards, Strategic Planning, Time Management, Trend Analysis
LOCATION
Philadelphia, PA
POSTED
30+ days ago

Responsibilities: Key Responsibilities: Serve as a key clinical science contributor for assigned CAR-T programs, partnering with the Medical Director and other Clinical Development team members to support study design, execution, and interpretation across all phases of clinical development. Lead or contribute to the preparation of key clinical documents - including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs, BLAs/MAAs). Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration. Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy. Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations. Collaborate with the Medical Monitor to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities. Lead or support governance activities, including preparation and presentation of materials for Development, Executive, and Scientific Steering Committees, as well as oversight of external boards (e.g., DSMB, adjudication committees). Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, regulatory interactions). Serve as the clinical science representative on cross-functional development and study teams, providing scientific and strategic input to ensure cohesive execution. Mentor study team members and contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables. Maintain awareness of emerging scientific and regulatory trends in cell and gene therapy and autoimmune diseases to integrate innovations into development strategy. Other related duties, as assigned Qualifications:

About the Company

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Cabaletta Bio Inc