Senior Manager / Associate Director, Clinical Development (Ophthalmology)

Overview

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Senior Manager / Associate Director, Clinical Development (Ophthalmology) will play a key role in the execution and oversight of clinical trials, ensuring the highest standards of data quality, participant safety, and cross-functional selection. This individual will leverage their expertise in data review, trial management, and site communication to partner with the Priovant Medical Monitor and cross-functional stakeholders to drive the success of global, late-stage, pivotal trials in ophthalmology.

Responsibilities

• Under the supervision of the study clinical lead, conduct comprehensive data quality reviews, including assessments of trial participant eligibility, evaluation of laboratory and other clinical data, reporting of adverse events, and protocol deviations
• Ensure the accuracy and integrity of clinical data in alignment with study protocols and regulatory requirements
• Partner with clinical operations, safety, regulatory, and other key functions to ensure seamless, rapid, and high-quality trial execution
• Act as a scientific resource for internal and external discussions of the trial protocol and clinical data
• Engage with external vendors including CROs and central imaging readers to ensure quality trial execution
• Foster productive relationships with clinical trial sites and investigators, addressing clinical inquiries and supporting protocol compliance
• Support generation of clinical development documentation, including study protocols, eligibility reports, and monitoring plans
• Prepare materials for medical conferences, safety and data review committees, and other clinical development activities, as directed
• Identify discrepancies or uncertainties in trial data, submit queries to sites, and facilitate prompt issue resolution
• Limited travel for study-related and company meetings
  
  

Qualifications

• Advanced degree (PhD, PharmD, or equivalent) in a life science, clinical, or health-related field
• Minimum of 3 years in drug development, with a preference for direct experience in ophthalmology or autoimmune disease trials in small biotech
• Proven expertise in clinical data quality review, participant eligibility assessment, and monitoring of laboratory and/or clinical data
• Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment
• Strong cross-functional collaboration skills, with a demonstrated ability to work effectively with clinical operations and other functions
• Experience managing external vendors
• Familiarity with regulatory requirements and clinical trial processes
• 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