Clinical Monitoring Associate Jobs in Boston, MA

CRISPR 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.

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.