CRISPR Therapeutics

Title: Director, Clinical Development Location: South Boston United States Full time Job Description: Company Overview Founded 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 Summary Reporting 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. 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.

Title: Manager, Clinical Data Management Location: South Boston, MA Job Description: Full time job requisition id R-100068 Job Description: Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies 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, and business offices in London, United Kingdom. Position Summary The Manager of Clinical Data Management will lead clinical data management activities in support of CRISPR studies across all stages of clinical development. They will ensure that clinical data capture, systems and processes will ensure accurate, consistent, high quality, and complete data. The successful candidate will provide clinical data management oversight of outsourced clinical trials, including but not limited to: project management, vendor management, coordination of internal reviews, and approval of deliverables. The candidate will impact multiple clinical development programs, health authority submissions, presentations and publications across internal and external stakeholders. Responsibilities - Plan, coordinate, and manage data management tasks and timelines. - Act as primary liaison with CROs, third party data vendors, and EDC vendors. - Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed. - Primary author/approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third party vendor data specifications. - Oversee database design, production and UAT cycles, ensuring that the CRO meets the highest quality standards. - Accountable for external data vendor documentation, management, and reconciliation. - Contribute to departmental SOP and process development and improvement, and integration of technology. - Perform and/or review medical coding and SAE reconciliation. - Support internal review/QC of clinical data. - Support GCP inspection readiness. Minimum Qualifications - Bachelor’s degree in a health-related field is required, Master’s degree strongly preferred - Minimum of 7+ years of progressive experience in clinical data management in a regulatory environment. - Demonstrated proficiency managing the lifecycle of clinical data projects. - Experience developing reports using J-Review, Business Objects, or other CDM reporting tools. - Experience with EDC databases, especially Medidata Rave. - Experience with CDASH/SDTM/CDISC standards. - Experience working with central and specialty labs/vendors. - Working knowledge of medical terminology and medical coding dictionaries including MedDRA and WHO. - Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management. - Ability to manage multiple initiatives and shifting priorities within a small, fast paced company environment. - Strong analytical and problem-solving skills that meet or improve the status quo. - Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment. - Excellent written and oral communication skills. Preferred Qualifications - Prior experience working in a small or medium-sized biotech or pharmaceutical company 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. Manager: Base pay range of $123,000 to $133,000+ 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.

Title: Scientist II, Computational Biology & AI remote type Site Based Locations South Boston, MA Full time Job requisition id R-100067 Job Description: Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies 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 Summary We are seeking a highly motivated and talented Computational Biology & AI Scientist to grow our CRISPR-X and Genomics teams at CRISPR Therapeutics. The scientist in this role will leverage computational genomics and machine learning to advance next-generation in vivo therapies for gene correction and gene insertion into the clinic, including designing novel CRISPR proteins and characterizing gene-editing safety. The successful candidate will own technical strategy, collaborate closely with cross-functional research groups, and deliver contributions that directly impact patients with serious diseases. The position requires outstanding skills in computational biology, ML/AI, and genomics; a high degree of scientific rigor and attention to detail; and a passion for creating new medicines for patients. Responsibilities - Lead computational genomics and ML/AI activities in a cross-functional drug development setting - Generate and test hypotheses on genome-scale data using analytical, statistical, and machine learning methods - Perform computational analyses to thoroughly characterize off-target gene editing to ensure the safety of CRISPR-based drug products - Apply and develop ML/AI tools to engineer and optimize CRISPR and other gene-editing modalities for improved efficacy and specificity, working in iterative design-test cycles with a world-class team of cellular and molecular biologists - Develop and maintain reproducible computational and ML/AI pipelines for genomic and molecular data analysis - Author scientifically rigorous research reports to support IND submissions and other regulatory filings - Present scientific findings to a broad range of audiences, including senior leadership, to help inform decision-making for therapeutic programs - Dissect published literature and cutting-edge developments in the ML/AI space to find novel solutions for in vivo gene-editing problems Minimum Qualifications - Ph.D. in computational biology, bioinformatics, genomics, machine learning, computer science, or a related field - At least 2 years of industry or postdoctoral experience characterizing on-/off-target editing, optimizing gene-editing modalities, or developing AI/ML-driven approaches for therapeutic protein design - Demonstrated record of developing computational pipelines to analyze high-throughput DNA sequencing data, with proficiency in common bioinformatics tools (e.g., BWA, SAMtools, GATK, IGV) - Proven ability to develop and apply machine learning and/or AI methods to solve challenging problems in the biological domain - Proficiency with Python is essential; familiarity with additional languages such as C++, R, or Julia is a plus - Ability to work independently and effectively in a matrix environment, prioritize and manage multiple tasks simultaneously, and balance competing priorities - Excellent writing, reviewing, and presentation skills - A high degree of scientific rigor, accuracy, and attention to detail Preferred Qualifications - Experience applying ML/AI tools for protein structure prediction (e.g., AlphaFold), de novo protein design (e.g., RFdiffusion), and/or biomolecular sequence modeling (e.g., ESM, Evo) - Proficiency with statistical and machine learning methods, including familiarity with ML frameworks (e.g., PyTorch, TensorFlow, or scikit-learn) - Familiarity with sequencing platforms (Illumina, PacBio, Oxford Nanopore, 10x Genomics) and NGS library preparation methods - Demonstrated record of authoring research reports to support regulatory filings (e.g., IND modules, Investigator's Brochures) - Proficiency in managing and analyzing large-scale genomic data in a Linux and/or cloud environment (e.g., AWS) Competencies - Collaborative – Openness, One Team - Undaunted – Fearless, Can-do attitude - Results Orientation – Delivering progress toward our mission. A 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. Scientist II: Base pay range of $140,000 to $150,000+ 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.