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Director
Boston, MA
Job Description
08-Oct-2019
Director, In Vivo Pharmacology
Watertown, MA
Full-Time
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
#LI-SL1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
Vertex is consistently recognized as one of the industry's top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit www.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 Talent Acquisition at ApplicationAssistance@vrtx.com.
Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
Vertex is consistently recognized as one of the industry's top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit www.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 Talent Acquisition at ApplicationAssistance@vrtx.com.
Req ID
12502BR
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Doctorate
Required Experience
10+ years
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