Job Description:Position SummaryReporting 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.
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
Minimum Qualifications- 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
Preferred Qualifications- 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
Competencies- 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. Ownership mindset.
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. Certain lab based and manufacturing positions are located fully on-site.
Director, Clinical Development: Base pay range of $210,000 to $225,000+ bonus, equity and benefits
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
