Medical Director (Early Development) at Vertex 9/16/2017
JOB DESCRIPTIONAPPLY Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
The successful candidate will be a strategic, hands-on early development medical expert with the responsibility for overseeing the transition of research projects into clinic development and for the strategy for early development across disease areas. As the Early Development Medical Director, the candidate will work closely with other functional experts across the organization. This role may lead or participate on cross-functional Project Teams to develop an early clinical development path which is innovative, safe and creates a foundation for decision making. The candidate will provide medical leadership in early clinical phase, as well as being responsible for the medical aspects of Phase I studies throughout development. This includes utilization and support for innovative biomarkers to support decision making in the early phases of development. The role will provide translational medicine expertise and to support Clinical Pharmacology and Biomarkers contributions to project teams.
This position will report into the Head of Clinical Pharmacology&Biomarkers and will be a critical element in Vertex s approach to create an effective bridge between discovery research and clinical R&D.
Provide clinical leadership to drive the design and interpretation of early clinical development studies, in close collaboration with experts in Clinical Biomarkers and Pharmacokinetics within the department.
Work with Clinical Study Teams and clinical colleagues to ensure effective execution of early phase and Clinical Pharmacology studies within the portfolio, in healthy volunteers and patients as appropriate.
Responsible, in collaboration with Global Patient Safety for the safety evaluation in early development programs(s).
Support exploratory biomarker efforts to aid in clinical and project decision making
Serve as a key member of cross-functional Project Teams, providing expert translational input and guidance during early stages of clinical development.
Work with colleagues across the clinical and research organizations to foster an end-to-end view of drug development, with a focus on improving patient care.