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Job Description
Vertex Pharmaceuticals is working to discover and develop innovative genetic therapies with the potential to provide transformative benefit to patients. Vertex is currently advancing multiple CRISPR-based genetic therapies that have the potential to cure or stop the progression of disease, including for degenerative neurological and muscular diseases. Vertex is seeking a creative, self-motivated individual with a passion for science to join our team. This is a fantastic opportunity to work on cutting edge science, apply state-of-the-art gene editing technologies, and take part in discovering and developing next-generation therapies for Duchenne Muscular Dystrophy, Myotonic Dystrophy Type 1 and other genetic disorders.
KEY RESPONSIBILITIES
- Assume responsibility for IND-enabling in vivo studies to advance our lead development programs, including study planning, protocol design, study execution, data analysis and study report writing
- Manage in vivo model development and characterization
- Oversee CRO management for outsourced preclinical activities
- Author, review and finalize study reports, IND sections and responses to regulatory agency questions
- Assume responsibility for a small group of Scientists and Research Associates supporting in vivo pharmacology
- Ensure all IND-enabling in vivo studies are conducted in compliance with the appropriate regulatory guidance documents and are aligned with regulatory agency expectations.
- Implement and maintain good documentation practices
- Effectively collaborate with a fully integrated team to facilitate the success of projects
REQUIREMENTS
- PhD or equivalent in a relevant biological discipline and at least 10 years of relevant pharmaceutical industry experience
- Extensive experience overseeing preclinical study design and execution and in vivo model development
- Expertise in CRO management and oversight for in vivo studies
- Demonstrated contributions to regulatory submissions (e.g. INDs, BLAs) and implementation of good documentation standards to support regulatory filings
- Working experience with AAV vectors and/or CRISPR/Cas9 system
- Deep understanding of drug discovery, applied pharmacology and drug development
- Familiarity with the preclinical regulatory requirements for gene therapy/editing programs.
- Excellent communication skills with the proven ability to work effectively as a member of a multidisciplinary team
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Human Resources at ApplicationAssistance@vrtx.com.