Associate Director/Director, Clinical Development

Crispr Therapeutics Inc in; Framingham (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking an Associate Director or Director of Clinical Development to lead early-stage clinical programs. This pivotal role involves providing clinical and scientific input, overseeing clinical study deliverables, and collaborating with diverse teams to ensure effective execution of clinical trials. The ideal candidate will possess a Medical Doctorate and extensive experience in clinical research, particularly in cardiovascular diseases or genetic medicines. Join a dynamic workplace that values collaboration and mentorship, offering the chance to contribute to groundbreaking advancements in gene editing and transformative therapies.

Qualifications

• 5+ years of clinical research experience for Associate Director role.
• 8+ years of experience in clinical research or industry for Director role.

Responsibilities

• Oversee clinical study deliverables and review patient data.
• Collaborate with internal stakeholders to ensure operational deliverables.

Skills

Clinical Research

Medical Monitoring

Data Analysis

Communication Skills

Regulatory Knowledge

Education

Medical Doctorate (MD, DO)

PhD, PharmD, or MPH

Job description

Associate Director/Director, Clinical Development (Project Management)

Job Description:

Company Overview

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.

Position Summary

Reporting to the Executive Director of Clinical Development, the Associate Director or Director (AD/Dir) will provide clinical and scientific input and medical monitoring to early-stage clinical development programs. The AD/Dir will have a significant role in clinical study oversight and deliverables, including review of patient data, input on clinical trial design and execution, and preparation/presentation to leadership, at conferences, and to safety oversight committees.

Responsibilities

1. 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)
2. Perform review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency and completeness and providing assessments and recommendations
3. Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study
4. Communicate a clear overview of trial results
5. 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
6. Review and synthesize scientific literature and competitive intelligence to support study and program strategy
7. Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials
8. Drive and support preparation of scientific material for conference presentations or publications
9. Contribute to the authoring and revision of regulatory submissions
10. Perform analyses and generate scientific slide decks based on clinical, translational, and other datasets

Minimum Qualifications

• 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 Qualifications

• 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

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.

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.