Sr. Director, Clinical Scientist

Role Summary

The Sr. Director, Clinical Scientist plays a pivotal role in shaping the clinical development strategy for the company’s CAR-T cell therapy programs in autoimmune diseases. This leader drives the scientific and clinical integrity of trials from early proof-of-concept through late-stage pivotal studies, partnering closely with Clinical Operations, Translational Medicine, Regulatory, and Biostatistics to ensure high-quality data and alignment toward a successful BLA submission. They serve as the scientific bridge between discovery and clinical execution, providing deep expertise in autoimmune diseases, cell therapy, and clinical trial design to advance transformative therapies for patients.

Responsibilities

• Serve as the clinical science lead for assigned CAR-T programs, partnering with the Medical Director on the design, execution, and interpretation of clinical studies across all phases of development.
• Author and oversee key clinical documents ‚Äî 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.

Qualifications

• Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
• 7+ 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‚Äîparticularly in CAR-T or T-cell‚Äìbased modalities‚Äîstrongly 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.