Principal Safety Physician (MD)- CAR T Programs

Arbeitsbeschreibung

We are seeking a highly experienced and strategic Patient Safety Physician (MD) to lead safety activities for our CAR-T clinical development programs. This role is pivotal in shaping the safety profile of our innovative cell therapies, ensuring patient safety, regulatory compliance, and scientific excellence across the product lifecycle.

Key Responsibilities

• Lead ongoing safety signal detection, evaluation, and benefit-risk assessments across clinical trials and postmarketing settings.

• Serve as the primary author of safety sections in protocols, Investigator’s Brochures, CSRs, DSURs, RMPs, and regulatory documents/responses.

• Represent Drug Safety on Global Development and Product Teams, providing expert input on safety strategy, protocol design, and regulatory interactions.

• Prepare and lead Safety Review Committee (SRC) and Data Safety Monitoring Board (DSMB) meetings, including data analysis and presentation of safety findings.

• Present at internal governance forums such as the Global Safety Leadership Committee (GSLC) and SRC, delivering strategic safety insights.

• Collaborate cross-functionally with Clinical Research, Regulatory, Biostats, Medical Affairs, and external partners to align on safety deliverables.

• Ensure data integrity and compliance in safety databases and clinical trial systems.

• Drive innovation in safety science, including the use of real-world evidence and advanced analytics.

• Lead process improvements and contribute to the development of safety monitoring standards and tools.

• Mentor junior safety scientists and contribute to internal training and capability-building initiatives.

• Support inspection readiness and contribute to successful global regulatory submissions.

• Lead strategic planning for safety operations, including SOP updates, audits, and business continuity.

Basic Qualifications:

• MD or equivalent with 4+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration

Preferred Qualifications:

• 5+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration.

• Completion of residency or subspecialty fellowship preferred.

• Clinical experience in oncology, rheumatology, and/or neurology strongly preferred.

• Experience with Cell or Gene Therapy, other immunotherapies (T-cell Engagers, Checkpoint Inhibitors) and/or Inflammation therapies.

• Proven ability to work in matrixed environments

• Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.).

• Proficiency in safety databases (e.g., ARISg, Argus) and signal detection tools (e.g., Empirica, Spotfire).

• Exceptional communication, collaboration, and project management skills.

• High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset.