Job Description:Position SummaryCRISPR Therapeutics is searching for an Associate Director, Clinical Scientist to provide scientific input for early and late stage clinical development programs.
Responsibilities- Contribute to the scientific development of clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs)
- Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations
- Significantly contribute to the oversight of the clinical study in collaboration with the clinical development lead
- Present data and information to investigators and internal stakeholders, contributing to meetings with governance bodies and regulatory authorities
- Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
- Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions
- Support study execution as the scientific subject matter expert
- 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
- Provide mentorship to junior clinical scientists
Minimum Qualifications- Advanced scientific or clinical degree (eg MD, PhD, PharmD, DNP, MSN , etc). with 8-12+ years of relevant experience in clinical or related research
- Excellent oral and written communication skills and analytical skills
- Deep expertise in clinical science, with a strong track record of contributing to clinical studies
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- In-depth understanding of clinical development processes, regulatory requirements, and guidelines (FDA, EMEA, ICH, GCP)
- 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- Experience in cellular therapies/CAR-T trials
- Experience in Phase 1/Phase 2 clinical trials
Competencies- Collaborative - Openness, one team, positivity
- Undaunted - Fearless, can-do attitude, self-starter
- Results Orientation - Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; Practical
- Entrepreneurial Spirit - Proactive; Ownership mindset; Thinks outside the box
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.
Associate Director, Clinical Scientist: Base pay range of $170,000 to $185,000+ 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.
