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
Requirements
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
Clinical or research experience in autoimmune CAR-T trials
Strong track record of drug development in an industry setting
Proven history of effectively guiding and developing clinical development colleagues
Integrity, honesty and highest ethical standards and a sense of personal accountability
Quickly adapt and provide innovative solutions to challenges as they present themselves
Competencies
Collaborative - Openness, One Team
Undaunted - Fearless, Can-do attitude
Results Orientation - Deli
Benefits
Vision insurance
Additional Information
Job Description:
Company Overview
Founded over a decade ago, CRISPR Therapeutics is 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 Therapeutics is 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 AG is headquartered in Zug, Switzerland , with its wholly-owned U.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.
Crisprtx · South Boston, MA