Director, Clinical Development AID

CRISPR Therapeutics•Boston, MA

2d•$190,000 - $220,000•Hybrid

About The Position

Job Description: 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 Minimum Qualifications Medical Doctorate (MD, DO) 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 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. 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. Base pay range of $190,000 to $220,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. 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 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. 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

Requirements

Medical Doctorate (MD, DO)
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

Nice To Haves

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

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