Associate Clinical Research Director providing medical expertise to clinical studies and supporting development activities in a global biopharmaceutical company. Collaborating with stakeholders to ensure optimal study execution.
About the role
- Ophthalmology Clinical Scientist leading scientific planning and execution of clinical trials. Collaborating in a global, cross-functional team to ensure quality and integrity of trial conduct.
Responsibilities
- Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s)
- Serving as the lead clinical scientist on the clinical trial team
- Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director
- Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments)
- Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Providing tactical/scientific mentorship to other clinical scientists
Requirements
- Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
- Experience in conducting global clinical trials, including trial initiation through database lock
- Experience in conducting clinical trials in ophthalmology, such as uveitis, AMD (age-related macular degeneration), thyroid eye disease
- Experience in developing protocols and study related documents for ophthalmology clinical trials
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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