Associate Director​/Director, Clinical Development

Job Description Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines.

To accelerate and expand its efforts, CRISPR Therapeutics established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug Gl Switzerland, with its wholly‑owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Reporting to the Executive Director of Clinical Development, the Associate Director or Director (AD/Dir) will provide clinical and scientific input and medical monitoring to early‑stage clinical development programs. The AD/Dir 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/.

• Contribute to 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 সুঞ, ICFs, CSRs)
• Perform review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency मुझे completeness and providing assessments and recommendations
• Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study
• Communicate a clear overview of trial results
• Collaborate with internal stakeholders (including clinical operations, data management, statistics, safety, regulatory affairs, among others) to ensure translation of the clinical protocol into Conclusion 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 materialিকল্প 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

• Medical Doctorate (MD, DO, or equivalent ex‑US medical degree).
• Associate Director: 5+ years of clinical/related research experience (including residency and fellowship)
• Director: 8+ years of previous experience in clinical/related research (including residency and fellowship) or industry experience
• 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 h-thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators

• Clinical experience in cardiovascular diseases; clinical or research experience with genetic medicines, prior work on cardiovascular clinical trials a plus
• Advanced clinical training or a scientific degree (e.g., PhD, Pharm
  
  D, MPH, etc.) is a plus.
• Industry experience

• 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.…