Director, Clinical Development

CRISPR Therapeutics•South Boston, MA

1d•Hybrid

About The Position

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 Director will provide clinical and scientific input and medical monitoring to early-stage clinical development programs in autoimmune diseases. The Director will have a significant role in clinical study oversight and deliverables, including review of patient data, input on clinical trial design and execution, and preparation/presentation to leadership, at conferences, and to safety oversight committees.

Requirements

Medical Doctorate (MD, DO)
Advanced clinical training or a scientific degree in immunology (eg PhD, PharmD, MPH, etc) a plus
8+ years of previous experience in clinical or related research preferred
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

Nice To Haves

MD with a strong clinical or biopharmaceutical background in caring for patients with autoimmune diseases
Clinical or research experience in immunology; prior work in rheumatology or autoimmune CAR T trials a plus

Responsibilities

Lead the scientific development of 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 during the conduct of the study
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
Contribute to the authoring and revision of regulatory submissions
Perform analyses and generate scientific slide decks based on clinical, translational and other datasets