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CRISPR Therapeutics · 5 hours ago

Associate Director/Director, Clinical Development

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$150K/yr - $190K/yr

5+ years exp

CRISPR Therapeutics is a pioneering company in gene editing with a diverse portfolio of product candidates. They are seeking an Associate Director or Director of Clinical Development to provide clinical and scientific input to early-stage clinical programs, oversee clinical studies, and collaborate with various stakeholders to ensure successful execution of clinical trials.

BiopharmaBiotechnologyGeneticsMedical

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 review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency and completeness and providing assessments and recommendations

Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study

Communicate a clear overview of trial results

Collaborate with internal stakeholders (including clinical operations, data management, statistics, safety, regulatory affairs, among others) 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

Qualification

Clinical DevelopmentMedical MonitoringRegulatory SubmissionsClinical Trial DesignData AnalysisICHGCP FamiliarityAnalytical SkillsTeam-based EnvironmentProactive MindsetCommunicationCollaborative Work

Required

Medical Doctorate (MD, DO, or equivalent ex-US medical degree)

Associate Director: 5+ years of clinical/related research experience (including residency and fellowship)

Director: 8+ years of previous experience in clinical/related research (including residency and fellowship) or industry experience

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

Clinical experience in cardiovascular diseases; clinical or research experience with genetic medicines, prior work on cardiovascular clinical trials a plus

Advanced clinical training or a scientific degree (e.g. PhD, PharmD, MPH, etc.) is a plus

Industry experience