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 SummaryReporting 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.ResponsibilitiesLead 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 recommendationsServe as the clinical development lead during the conduct of the studyCommunicate 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 publicationsContribute to 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 or a scientific degree in immunology (eg PhD, PharmD, MPH, etc) a plus8+ years of previous experience in clinical or related research preferredExcellent 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 QualificationsMD with a strong clinical or biopharmaceutical background in caring for patients with autoimmune diseasesClinical or research experience in immunology; prior work in rheumatology or autoimmune CAR T trials a plusCompetenciesCollaborative – 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.Director, Clinical Development: Base pay range of $210,000 to $225,000+ 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.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.To view our Privacy Statement, please click the following link:
Director, Clinical Development
CRISPR-THERAPEUTICS-1
boston, boston
Published 4 days ago
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