Executive Director, Clinical DevelopmentReporting to the Vice President of Clinical Development, the Executive Director will provide clinical development strategy, mentoring of clinical development leads, medical monitoring and clinical and scientific input to all stages of zugocaptagene-geleucel clinical development autoimmune programs. The Executive Director will have a significant role in overseeing and designing multiple clinical studies, and ensuring deliverables are met across the studies, including review of patient data, and preparation/presentation to leadership, at conferences, and to safety oversight committees.ResponsibilitiesDevelop the clinical development strategy for the zugocaptagene-geleucel autoimmune program, including development of early and late-stage study designs, protocol and investigator brochure development, briefing books, and other regulatory documents and interactionsMentor team of clinical development leads in developing 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 recommendationsBuild and maintain relationships with thought leaders, clinical investigators, and partners to inform study design and program directionServe as the clinical development lead of one or more studiesCommunicate a clear overview of trial resultsCollaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverablesReview and synthesize scientific literature and competitive intelligence to support study and program strategyDevelop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materialsDrive and support preparation of scientific material for conference presentations or publicationsLead and oversee clinical development leads in the authoring and revision of regulatory submissionsPerform analyses and generate scientific slide decks based on clinical, translational and other datasetsMinimum QualificationsMedical Doctorate (MD, DO)Advanced clinical training in Rheumatology15+ years of previous experience in clinical or related research preferredHistory of mentoring and/or directly managing individuals in a team-based matrix environmentExcellent oral and written communication skills and analytical skillsAbility to work collaboratively in a fast-paced, team-based matrix environment; ability to assume multiple roles and responsibilities and meet stretch goalsFamiliarity 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 investigatorsPreferred QualificationsClinical or research experience in autoimmune CAR-T trialsStrong track record of drug development in an industry settingProven history of effectively guiding and developing clinical development colleaguesIntegrity, honesty and highest ethical standards and a sense of personal accountabilityQuickly adapt and provide innovative solutions to challenges as they present themselvesCompetenciesCollaborative – Openness, One TeamUndaunted – Fearless, Can-do attitudeResults 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.Executive Director, Clinical Development: Base pay range of $290,000 to $315,000+ bonus, equity and benefitsThe 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.