In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat-and even cure-several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex's continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies including use of small molecules and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.
Vertex/VCGT is searching for an experienced Senior Medical Director to assist in managing assets in its development portfolio related to DMD, DM1, and other neurology related VCGT disease areas. This is an excellent opportunity for a motivated drug developer to substantially shape the Neurology pipeline at VCGT. The Senior Medical Director will drive the clinical development strategy, work with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution, and may serve as the Medical Lead and primary Medical Monitor for clinical trials that will be conducted for specific compounds.
Drive the strategy and delivery of the clinical development plans, in conjunction with other relevant functional areas
Participate in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance
Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate
Interface with regulatory authorities as appropriate
Act as liaison between clinical development and other internal groups at Vertex/VCGT for assigned studies
Provide medical leadership for cross-functional teams, including external innovation/business development
Represent Vertex/VCGT to outside medical personal in the development of clinical protocols and study conduct
Represent Vertex/VCGT to outside stakeholder, including patient advocacy groups
MD, or DO
Board certification/eligibility in adult neurology, or another relevant specialty area including, but not limited to, neuromuscular, neurodegenerative, is highly desired
Minimum of 5 years Pharmaceutical/Biotech industry experience, including time managing clinical trials, leading creative teams and clinical development programs
Global clinical research experience and experience interacting with regulatory authorities and orphan patient advocacy groups
Ability to work collaboratively in a fast-paced, team-based matrix environment
Ability to work independently to resolve challenges
Excellent oral and written communication skills
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 Pharmaceuticals, Inc