Executive Director, Clinical Development

reputed company: reputed company Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company reputed company on developing transformative gene-based medicines for serious reputed company diseases. reputed company has evolved from a pioneering research-stage organization into an industry leader, marking a historic reputed company 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 reputed company pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. reputed company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to reputed company precise, efficient, and reputed company gene correction. To accelerate and expand its reputed company, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including reputed company. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, reputed company., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position reputed company Reporting to the Vice President of Clinical Development, the Executive Director will reputed company clinical development reputed company, mentoring of clinical development leads, medical monitoring and clinical and scientific input to reputed company 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 reputed company committees. Responsibilities reputed company the clinical development reputed company 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 interactions Mentor 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) reputed company review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency and completeness and providing assessments and recommendations Build and maintain relationships with thought leaders, clinical investigators, and partners to inform study design and program direction Serve as the clinical development reputed company of one or more studies Communicate a reputed company reputed company of trial results Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, reputed company, 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 reputed company reputed company scientific and protocol training presentations to support reputed company meetings; e.g., site qualification and initiation, investigator meetings, and training materials reputed company and support preparation of scientific material for conference presentations or publications reputed company and reputed company clinical development leads in the authoring and revision of regulatory submissions reputed company analyses and reputed company scientific slide decks based on clinical, translational and other datasets Minimum Qualifications Medical Doctorate (MD, DO) reputed company training in Rheumatology 15+ years of previous experience in clinical or reputed company research preferred History of mentoring and/or directly managing individuals in reputed company-based reputed company environment Excellent oral and written communication skills and analytical skills Ability to work collaboratively in a fast-paced, team-based reputed company 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, reputed company Assurance) and clinical investigators Preferred Qualifications Clinical or research experience in autoimmune CAR-T trials Strong reputed company record of drug development in an industry setting Proven history of effectively guiding and developing clinical development colleagues reputed company, honesty and highest ethical standards and a reputed company of personal accountability Quickly adapt and reputed company reputed company to challenges as they present themselves Competencies reputed company – Openness, One Team Undaunted – reputed company, Can-do attitude Results Orientation – Delivering reputed company toward our mission. reputed company of urgency in solving problems. Entrepreneurial Spirit – Proactive. Ownership reputed company. 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 reputed company work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to reputed company. Certain lab based and manufacturing positions are located fully on-site. Executive Director, Clinical Development: reputed company pay reputed company of $290,000 to $315,000+ bonus, equity and benefits The reputed company provided is CRISPR Therapeutics’ reasonable estimate of the reputed company compensation for this role. The actual reputed company will be based on job-reputed company and non-discriminatory factors such as experience, training, skills, and abilities. reputed company. is committed to equal employment opportunity and non-discrimination for reputed company and reputed company applicants without reputed company to a person's race, reputed company, gender, age, religion, national reputed company, reputed company, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To reputed company our reputed company Statement, please click the following reputed company: http://www.crisprtx.com/reputed company/reputed company-policy 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 reputed company of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-reputed company 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 reputed company. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, reputed company., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. reputed company. is committed to equal employment opportunity and non-discrimination for reputed company and reputed company applicants without reputed company to a person's race, reputed company, gender, age, religion, national reputed company, reputed company, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To reputed company our reputed company Statement, please click the following reputed company: http://www.crisprtx.com/reputed company/reputed company-policy Apply tot his job Apply To this Job