Posted in Research 30+ days ago.
Type: Full Time
Job DescriptionReporting to the SVP, Ophthalmology Franchise, the position is responsible for developing and implementing the development strategy for each asset assigned, including the design, conduct, interpretation of data from phase 3 studies as well as oversight of clinical pharmacology and pediatric studies as required to fulfill regulatory requirements.
The Ophthalmology Franchise Global Clinical Development Lead represents R&D on joint development and steering committees for partnered programs and in this regard has frequent interactions with Executive management internally and externally. This individual has accountability for developing/updating, with Early Development and Commercial colleagues, the disease area strategy for the Ophthalmology portfolio and for subsequently for driving business development activities consistent with this strategy.
* Direct the development of clinical strategies and plans to integrate compounds into standard practice
* Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities
* Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
* Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders
* Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
* Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners
* In addition to leading and supervising the Clinical Research Department, this role will have direct line responsibility for the Clinical Affairs and Clinical Operations Departments.
This position will be located in Waltham, MA with expected travel to Cambridge, MA and EU.
Qualifications* 10 years minimum experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs.
* Multiple years of management experience leading a clinical group includ
Additional InformationThe Ophthalmology Franchise Global Clinical Development Lead will provide leadership and direction for the pipeline of clinical development programs in inherited Retinal Diseases. The successful candidate will be responsible for developing and implementing the overall clinical strategy for the company. They will emphasize early clinical development of the lead asset and be credible within the clinical function, bringing a high level of leadership and accountability.