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

Reporting to the Executive Director of Clinical Development, the Associate Director/Director, Clinical Scientist will provide scientific input to early-stage clinical development programs. They will be responsible for the review of patient data, they will give input on clinical trial design, and will aid in preparation of data for presentation to leadership, at conferences, and to safety oversight committees.

Responsibilities

Contribute to 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 initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendationsContribute to the oversight in collaboration with the clinical development lead during the conduct of the studyAssist in communicating a clear overview of trial resultsCollaborate with internal stakeholders (clinical operations, data management, statistics, safety, regulatory affairs and program management) 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 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 datasets

Minimum Qualifications

PhD, RN, or NP with significant experience as a Clinical Scientist in a biopharmaceutical organizationAssociate Director: 6+ years of experienceDirector: 10+ years of experiencePrior experience as a Clinical Scientist in an industry settingExcellent oral and written communication skills and analytical skillsAbility to work collaboratively in a fast-paced, team-based matrix environmentFamiliarity 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 3-5+ years of biopharmaceutical experienceExperience in genetic medicinesPrior work on cardiovascular trials or cardiovascular clinical experienceClinical cardiovascular experience

Competencies

Collaborative – 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.

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: http://www.crisprtx.com/about-us/privacy-policy