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The Director, Clinical Scientist plays a key role in supporting the clinical development of the company’s CAR-T cell therapy programs in autoimmune diseases. This individual contributes to the scientific and clinical integrity of trials from early proof-of-concept through late-stage pivotal studies, working closely with Clinical Operations, Translational Medicine, Regulatory, and Biostatistics to help ensure high-quality data and alignment toward a successful BLA submission. They serve as an important scientific link between discovery and clinical execution, bringing expertise in autoimmune diseases, cell therapy, and clinical trial design to support the advancement of transformative therapies for patients.
Job Responsibility:
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)
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
Requirements:
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
Deep understanding of 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.