CRISPR Therapeutics
Director, Clinical Development leads scientific aspects of individual clinical studies in alignment with the clinical‑development plan. The role involves authoring and reviewing key clinical documents, reviewing trial data, serving as the clinical‑development lead during study conduct, and communicating trial results to stakeholders.
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 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 (e.g., PhD, PharmD, MPH) 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 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 neurology 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.
Base pay range $190,000 to $220,000 + bonus, equity and benefits.
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.
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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 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 (e.g., PhD, PharmD, MPH) 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 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 neurology 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.
Base pay range $190,000 to $220,000 + bonus, equity and benefits.
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.
#J-18808-Ljbffr