Priovanttx
Senior Director, Clinical Development
Priovanttx, Baltimore, Maryland, United States,
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Senior Director, Clinical Development will drive the execution, delivery, reporting and NDA submission of global late-stage trials, partnering with key stakeholders across the organization and engaging with the medical community and thought leaders to help achieve these goals.
Responsibilities
Lead or support clinical development programs in dermatology indications, including responsibility for clinical strategy, protocols, reports, and trial oversight
Provide input, authoring, and review of submission documents (IND, NDA, briefing documents)
Contribute scientific input into study design and execution, including selection of appropriate endpoints, patient populations, and study methodologies; site selection; investigator meetings; and study initiation activities
Monitor clinical trials for both quality and safety, ensuring adherence to protocols, timelines, and quality standards; review incoming medical data, including lab safety and efficacy data
Collaborate with clinical operations, medical affairs, regulatory affairs, biostatistics, and other teams to ensure alignment of clinical strategies with overall program goals
Collaborate with data management and biostatistics to develop and validate data collection tools and ensure accurate and timely data capture
Analyze clinical trial data, interpret results, and provide scientific insights to guide decision-making
Provide dermatology therapeutic area expertise at internal and external meetings as needed.
Represent Priovant at investigator meetings and scientific congresses, including to present study protocols and manage clinical/drug-related questions
Stay current with scientific literature and advancements in dermatology and related therapeutic areas
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
Partner with clinical operations to identify sites, execute on study design, and work with vendors
Occasional travel for study-related and company meetings
Qualifications
PharmD, PhD, MD, or equivalent
7+ years of clinical development experience, preferably including experiencein dermatology indications
Must have experience working in a small biotech
Must have experience with large, global Phase 3 registrational trials in rare disease or novel indications
NDA submission experience strongly preferred
Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
Ability to quickly assimilate technical and scientific information and consistently produce thorough and accurate work
Demonstrated communication, problem-solving, and decision-making skills
Natural collaborator who enjoys working on a cross-functional team
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