Hiring: Director, Clinical Scientist Company: Cabaletta Bio Location: Philadelphia, PA Job Posted Time: 2026-09-10 13:12:44 Employment Type: Remote Target Skills & Keywords : GCP About the job Experience: •5+ years of clinical development experience within biotech, pharmaceutical, or academic settings, with demonstrated leadership in advancing programs through early and late-stage development. Required Skills: •Or based out of our Philadelphia, PA headquarters •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. •Partner cross-functionally 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). Qualifications: •Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred •4-5+ years of clinical development experience within biotech, pharmaceutical, or academic settings, with demonstrated leadership in advancing programs through early and late-stage development. •Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred; autoimmune disease experience highly desirable. •Comprehensive expertise in T-cell biology, immunology, and translational science principles relevant to cellular therapy. •Proven ability to author and critically review clinical protocols, study reports, and regulatory documents, ensuring scientific integrity and compliance with ICH-GCP and global regulatory standards. •Demonstrated skill in analyzing complex clinical data, conducting literature reviews, and synthesizing insights to inform program strategy. •Exceptional scientific judgment, attention to detail, and analytical rigor. •Strong communication and collaboration skills, with the ability to influence and partner effectively across cross-functional teams, investigators, and external experts. •Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment. •For more information, please visit https://www.cabalettabio.com/join-our-crew Compensation: •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!