Executive Director, Clinical Development

Position Summary

Reporting to the Vice President of Clinical Development, the Executive Director will provide clinical development strategy, mentoring of clinical development leads, medical monitoring and clinical and scientific input to all stages of zugocaptagene-geleucel clinical development autoimmune programs. The Executive Director will have a significant role in overseeing and designing multiple clinical studies, and ensuring deliverables are met across the studies, including review of patient data, and preparation/presentation to leadership, at conferences, and to safety oversight committees.

Responsibilities

• Develop the clinical development strategy for the zugocaptagene-geleucel autoimmune program, including development of early and late-stage study designs, protocol and investigator brochure development, briefing books, and other regulatory documents and interactions

• Mentor team of clinical development leads in developing individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigators brochure, eCRFs, ICFs, CSRs)

• Perform review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency and completeness and providing assessments and recommendations

• Serve as the clinical development lead of one or more studies

• Communicate a clear overview of trial results

• Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables

• Review and synthesize scientific literature and competitive intelligence to support study and program strategy

• Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials

• Drive and support preparation of scientific material for conference presentations or publications

• Lead and oversee clinical development leads in the authoring and revision of regulatory submissions

• Perform analyses and generate scientific slide decks based on clinical, translational and other datasets

Minimum Qualifications

• Medical Doctorate (MD, DO)

• Advanced clinical training in Rheumatology

• 15+ years of previous experience in clinical or related research preferred

• History of mentoring and/or directly managing individuals in a team-based matrix environment

• Excellent oral and written communication skills and analytical skills

• Ability to work collaboratively in a fast-paced, team-based matrix environment; ability to assume multiple roles and responsibilities and meet stretch goals

• Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators

Preferred Qualifications

• Experience in clinical or research experience in autoimmune CAR-T trials

• Proven history of effectively guiding and developing clinical development colleagues

Competencies

• Collaborative – Openness, One Team

• Undaunted – Fearless, Can-do attitude

• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.

• Entrepreneurial Spirit – Proactive. Ownership mindset.