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Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Director/Senior Director, Clinical Development (Ophthalmology) will be responsible for clinical development in ophthalmology, including partnering with key stakeholders across the organization; engagement with the medical community and thought leaders; and supporting the execution of one or more global, late-stage, pivotal trials.
Responsibilities
Lead clinical development programs in ophthalmology indications, including responsibility for clinical strategy, protocols, and trial oversight
Provide ophthalmology therapeutic area expertise at internal meetings as needed
Serve as the Medical Monitor for assigned clinical trials, or provide supervision for the designated Medical Monitor, to ensure quality of trial execution and data collection
Provide safety oversight of clinical trials to ensure that safety concerns and/or adverse events are identified, reporting is complete, and that appropriate responses are taken
Represent Priovant at Investigator Meetings and scientific congresses, present the protocol and manage clinical/drug related questions
Establish and maintain relationships with investigators and key opinion leaders
Provide protocol-specific and therapeutic area training and advise sites/investigators on trial-related medical questions
Review of incoming medical data, including lab safety and efficacy data
Participate in the preparation of study protocols and other regulatory documents
Partner with Clinical Operations to identify sites, execute on study design, and work with vendors
Occasional travel for study-related and company meetings
Qualifications
MD, DO or equivalent
Completion of ophthalmology residency required
Experience working in a small biotech preferred
Completion of retina fellowship or equivalent preferred
4+ years of clinical development experience, including medical monitoring
Experience with medical affairs and/or pharmacovigilance preferred
Experience with large, global registrational trials preferred
Ability to quickly assimilate technical and scientific information and consistently produce thorough and accurate work
Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
Demonstrated communication, problem-solving, and decision-making skills
Natural collaborator who enjoys working on a cross-functional team
Seniority level
Director
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Technology, Information and Internet
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