Executive Director, Clinical Development

Executive Director, Clinical Development (Project Management)

Job Description:

Company Overview

Founded over a decade ago,CRISPR Therapeutic sis a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY ® (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.

CRISPR Therapeutic sis advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact,CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals .CRISPR

Therapeutics AGis headquartered inZug, Switzerland , with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

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
• Build and maintain relationships with thought leaders, clinical investigators, and partners to inform study design and program direction
• 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

• Medic…