Associate Director, Clinical Scientist

Job Description:Company OverviewFounded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including 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.Position SummaryCRISPR Therapeutics is searching for an Associate Director, Clinical Scientist to provide scientific input for early and late stage clinical development programs.ResponsibilitiesContribute 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 recommendationsSignificantly contribute to the oversight of the clinical study in collaboration with the clinical development leadPresent data and information to investigators and internal stakeholders, contributing to meetings with governance bodies and regulatory authoritiesCollaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverablesCollaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissionsSupport study execution as the scientific subject matter expertReview 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 materialsSupport preparation of scientific material for conference presentations or publicationsContribute to the authoring and revision of regulatory submissionsPerform analyses and generate scientific slide decks based on clinical, translational and other datasetsProvide mentorship to junior clinical scientistsMinimum QualificationsAdvanced scientific or clinical degree (eg MD, PhD, PharmD, DNP, MSN , etc). with 8-12+ years of relevant experience in clinical or related researchExcellent oral and written communication skills and analytical skillsDeep expertise in clinical science, with a strong track record of contributing to clinical studiesAbility to work collaboratively in a fast-paced, team-based matrix environmentIn-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 investigatorsPreferred QualificationsExperience in cellular therapies/CAR-T trialsExperience in Phase 1/Phase 2 clinical trialsCompetenciesCollaborative – Openness, one team, positivityUndaunted – Fearless, can-do attitude, self-starterResults Orientation – Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; PracticalEntrepreneurial Spirit – Proactive; Ownership mindset; Thinks outside the boxCRISPR 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 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.To view our Privacy Statement, please click the following link: #J-18808-Ljbffr Crispr-Therapeutics-1