CRISPR Therapeutics
Associate Director/Director, Clinical Development
Clinical Development - Boston, MA - Full Time
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 has established strategic partnerships with leading companies including Bayer and 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, and business offices in London, United Kingdom.
Position Summary
Reporting to the Senior Director of Clinical Development, the Associate Director/Director will provide clinical and scientific input to early-stage clinical development programs. The Associate Director/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.
Responsibilities
- 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, ICFs, CSRs)
- Perform review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing assessments and recommendations
- Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study
- Assist in communicating 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
- 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
Minimum Qualifications
- Advanced scientific or clinical degree (eg PhD, PharmD, MPH, etc).
- 5-8+ years of previous experience in clinical or related research
- 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
- MD with biopharmaceutical or relevant clinical research experience
- Clinical experience in autoimmune diseases; prior work on autoimmune trials a plus
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
