Contribute to the scientific development of clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs)
Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations
Significantly contribute to the oversight of the clinical study in collaboration with the clinical development lead
Present data and information to investigators and internal stakeholders, contributing to meetings with governance bodies and regulatory authorities
Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions
Support study execution as the scientific subject matter expert
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
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
Provide mentorship to junior clinical scientists
Requirements
Advanced scientific or clinical degree (eg MD, PhD, PharmD, DNP, MSN , etc). with 8-12+ years of relevant experience in clinical or related research
Excellent oral and written communication skills and analytical skills
Deep expertise in clinical science, with a strong track record of contributing to clinical studies
Ability to work collaboratively in a fast-paced, team-based matrix environment
In-depth understanding of clinical development processes, regulatory requirements, and guidelines (FDA, EMEA, ICH, GCP)
Strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
Results Orientation - Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; Practical
Entrepreneurial Spirit - Proactive; Ownership mindset; Thinks outside the box
Associate Director, Clinical Scientist: Base pay range of $170,000 to $185,000+ bonus, equity and benefits
The range provided is CRISPR Thera
Benefits
Vision insuranceRemote work optionsEquity / stock optionsPerformance bonus
Additional Information
Job Description:
Company Overview
Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone 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 diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, 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 .
Position Summary
CRISPR Therapeutics is searching for an Associate Director, Clinical Scientist to provide scientific input for early and late stage clinical development programs.
Crisprtx · South Boston, MA