Director/Medical Monitor (Clinical Development)

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Director, Clinical Development will be responsible for supporting the execution of Priovant’s clinical trials, with a focus on medical monitoring of global, late-stage, pivotal studies. She/he will also support long-term engagement with

Responsibilities

• Serve as the primary Medical Monitor for assigned clinical trials, ensuring medical and scientific quality of clinical trial execution
• Establish and maintain relationships with site investigators to ensure appropriate medical execution of study protocols
• Advise sites/investigate conduct of the trial
• Represent Priovant at Investigator Meetings, present the protocol and manage clinical/drug related questions
• Review medical data, including lab safety and efficacy data, and conduct eligibility review
• Provide protocol-specific and therapeutic area training for project team and sites (e.g., at site initiation visits)
• Review study protocols and associated plans
• Provide ongoing medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and that appropriate responses are developed and executed
• Review safety data to identify risk trends and present at functional meetings
• Assist in the study feasibility process by supporting site identification and selection
• Partner with Clinical Operations to execute on study design and work with vendors
• Analyze and evaluate data outcomes and communicate recommendations and next steps
• Provide medical expertise on cross-functional development team
• Occasional travel for study-related and company meetings

Qualifications

• MD, DO or equivalent
• 2+ years of Clinical Development experience, including medical monitoring
• Experience with rare disease/rheumatology/ophthalmology preferred
• Experience with late-stage development programs preferred
• Experience in small biotech or working on a small cross-functional team strongly 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