Clinical Director overseeing day - to - day operations of clinical programs in an eating disorder treatment facility. Ensuring high - quality care and compliance with regulations in Jacksonville, Florida.
About the role
- Lead Medical Director overseeing clinical development strategies for Roche’s ophthalmology division. Responsible for fostering cross-functional collaboration and ensuring execution of clinical plans.
Responsibilities
- Participate in development of the Clinical Development (CD) strategy
- Responsible for developing the CD plan
- Ensure effective and efficient CD plan execution for the assigned molecule(s)/indication(s)
- Lead and/or represent CD in sub-teams relevant to assigned molecule(s)/indication(s)
- Responsible for training new CST members
- Participates in ongoing enhancements/development of core and sub-team processes
- Provides clinical oversight across all relevant studies and programs
- Develop and deliver key presentations
- Collaborate with regulatory partners
Requirements
- M.D. with relevant medical experience in same/similar therapeutic area required
- 4 or more years pharma/biotech industry experience OR is a recognized expert in the field
- 4 or more years experience with clinical trials
- Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred
- Experience authoring aspects of a global clinical development plan or full clinical study protocol is preferred
- Experience publishing results of a clinical drug trial in a peer reviewed journal is preferred
- Knowledge/understanding of Phase I & IV drug development is a plus
- Academic/teaching background is a plus
- Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Comprehensive understanding of product and safety profiles
- Versed in medical aspects of GCP, ICH, FDA, EMEA, NICE and other relevant guidelines and regulations
- Familiar with competitive activity in the field
- Previous people management experience is a plus
Benefits
- Roche’s culture encourages personal expression
- Open dialogue
- Genuine connections
- Valued, accepted and respected
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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