Senior Director, Clinical Science

Team: Clinical

Location: Remote

Commitment: Full Time

Workplace Type: remote

Responsibilities

Serve as the senior clinical scientist for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams
Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution
Lead design, execution, and interpretation of clinical trials across assigned program
Provide scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
Participate in the development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities in collaboration with the study physician.
Represent Clinical Development for the assigned program with cross-functional leaders
Represent Clinical Development for the assigned program with key opinion leaders and strategic partners to inform clinical and scientific strategy
Represent Clinical Development for the study team in high-impact external settings (advisory boards, regulatory meetings, major congresses), as appropriate
Contribute to external scientific narrative and positioning through publications, presentations, and collaborations.
Ensure compliance with GCP, corporate policies, and applicable local regulations.
Lead, mentor, and develop high-performing clinical scientists and other staff
Foster a culture of innovation, accountability, and scientific rigor.
Contribute to Clinical Development organizational design and capability building to support future pipeline growth and complexity.

Qualifications

Advanced degree (Ph.D., Pharm.D., M.D., or equivalent) in a scientific or life sciences discipline required
10+ years of progressive experience in drug development, including significant experience across multiple programs, including late-stage global clinical trials
Demonstrated success in developing and executing clinical strategies at a program level
Experience in late-stage clinical trials required; experience with BLA/NDA filing preferred
Experience in cell and gene therapy, immunology, autoimmune disease, or related fields preferred
Deep understanding of global regulatory frameworks and clinical development pathways required
Strong operational acumen with excellence and efficiency
Exceptional communication and management skills
Ability to operate independently and effectively in a fast-paced, highly dynamic environment
Ability to travel up to 15% of the time