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Director, Clinical Research (Ophthalmology)

Connect Life Sciences
Marlborough, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Responsible for and lead all activities related to clinical study design from clinical study concept to clinical study protocol for both early- and late-stage programs Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required, and working with the safety group to ensure adequacy of safety monitoring and reporting Provide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc Study-level, site-level and subject-level data review and interpretation, including documentation and summarization of findings Serve as the internal medical monitoring for clinical trials Review and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output Contributes to interpretation of clinical trial results and the writing of clinical study reports Contributes to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific/regulatory/medical standards Contributes to developing clinical components of NDAs, sNDAs, MAAs and other regulatory filing documents Contributes to company responses to health authorities and ethics committees for ongoing clinical programs to ensure timely registration and initiation of trials globally Contributes to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings, and national and international scientific meetings.
Serve as the subject matter expert for ophthalmology, representing Clinical Research to both internal and external customers
Skills: Minimum Education, Experience, Knowledge and Skills Required:
MD (or international equivalent)
Board certified or board eligible in ophthalmology Fellowship training in vitreoretinal surgery (preferred) or retina A minimum of 5 years' experience in the pharmaceutical industry, ideally with a minimum of 5 years in Clinical Research / Clinical Development with experience in ophthalmology therapeutic area Experience in regenerative cell medicine or gene therapy preferred Knowledge and understanding of FDA, GCP, and ICH regulations and guidance Experience in conducting global clinical trials in both early- and late-stage clinical development Experience in regulatory submissions in US, Europe, and Japan Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community.

Connect Life Sciences

Address

Marlborough, MA
USA

Industry

Healthcare

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