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Global Clinical Development Lead - Ophthalmology Franchise | Franchise in Franchise Job Job at Bio1

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Global Clinical Development Lead - Ophthalmology Franchise

Cambridge, MA

SummaryThe Ophthalmology Franchise Global Clinical Development Lead will provide leadership and direction for the pipeline of clinical development programs in inherited Retinal Diseases. The successful applicant 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.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 three 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 Ru0026D 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.Position assignments:- Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities- Must be science- and data-driven.EducationMD required.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic details, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse applicants at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse applicants, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations- Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; background in interactions with FDA personnel is essential; background in interactions with other health authorities a plus- Background or knowledge of Orphan or genetic rare disease drug development a plus- 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.Requirements* 10yrs min background in clinical practice treating patients and pharmaceutical and/or biotechnology industry background as a sponsor working on investigational new drugs.- Direct the development of clinical strategies and plans to integrate compounds into standard practice- Background in translational medicine, clinical pharmacology and early stage development is desirable- Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results- Must have excellent leadership and people skills; should have proven skills as an effective team member who can engender credibility and confidence within and outside the company; must have outstanding executive presence.- Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders- Excellent knowledge of the competitive environment for drugs in the Ophthalmic marketplace and in research and development pipelines- Background with, or strong knowledge of Ophthalmic drug development- 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- Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy- Multiple years of managerial background leading a clinical group including clinical/medical affairs and clinical operations.- Must have a strong knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.- A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND's and marketing approval-directed filings (BLA's, NDA's, and MAA's)Additional Skills:
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More About this Listing: Global Clinical Development Lead - Ophthalmology Franchise
Global Clinical Development Lead - Ophthalmology Franchise is a Franchise Jobs Franchise Job at Biogen located in Cambridge MA. Find other listings like Global Clinical Development Lead - Ophthalmology Franchise by searching Oodle for Franchise Jobs Franchise Jobs.