Director/Senior Director, Clinical Development (Ophthalmology)
Director/Senior Director, Clinical Development (Ophthalmology)
Priovant Therapeutics
Durham, NC
See who Priovant Therapeutics has hired for this role
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
- 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
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Seniority level
Director -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Technology, Information and Internet
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