Apply on Employer Site

CRISPR Therapeutics · 8 hours ago

Director, Clinical Development AID

Boston, MA

Full-time

Hybrid

Director/Executive

$190K/yr - $220K/yr

8+ years exp

CRISPR Therapeutics is a leader in gene editing with a diverse portfolio of product candidates across various disease areas. The Director of Clinical Development AID will provide clinical and scientific input for early-stage clinical development programs in autoimmune diseases, overseeing clinical study deliverables and collaborating with various stakeholders to ensure successful execution of clinical trials.

BiopharmaBiotechnologyGeneticsMedical

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 for 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

Qualification

Medical DoctorateClinical research experienceImmunology expertiseAnalytical skillsICHGCPCommunication skillsResults OrientationEntrepreneurial SpiritCollaborative

Required

Medical Doctorate (MD, DO, MBBS)

Advanced clinical training or a scientific degree in immunology (eg PhD, PharmD, MPH, etc) 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 with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators