Priovant Therapeutics

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Central Data Monitoring Specialist (CDMS) supports monitoring and site data quality oversight activities across clinical studies. This role partners closely with Clinical Operations, Clinical Research Associates, Data Management, and external data vendors to proactively identify key data issues, generate actionable metrics, and ensure critical data cleaning activities are completed prior to and during on-site monitoring visits. The CDMS provides real-time remote support to optimize site visit productivity, ensure data integrity, and maintain regulatory compliance. S/he will report to the Director, Data Management. Responsibilities - Perform ongoing centralized review of study data to identify high-risk data trends, outliers, missing critical data, and potential protocol deviations. - Generate site-level data quality metrics and dashboards to support monitoring prioritization. - Identify key priority data requiring cleaning prior to on-site visits (e.g., eligibility criteria, primary endpoint data, SAEs, key safety labs). - Partner with Data Management to escalate systemic data trends or recurring discrepancies. - Prepare pre-visit data cleaning summaries and site-specific issue trackers for CRAs. - Highlight unresolved queries, overdue data entry, missing signatures, and critical form status gaps. - Provide structured pre-visit briefings to CRAs as needed. - Provide remote data review support while CRAs are on-site. - Monitor data changes in the EDC system and verify resolution of high-priority issues. - Assist CRAs with rapid identification of newly identified discrepancies. - Coordinate with Data Management for urgent query generation or clarification. - Track progress of issue resolution to ensure visit objectives are achieved. - Monitor sample management compliance from site to external vendor and from vendor to vendor. - Track site upload compliance for ECG data and Imaging files - Escalate delays in sample shipment or vendor uploads to Clinical Operations as appropriate. - Develop and maintain key performance indicators (KPIs) related to: - Query aging - Data entry timeliness - Critical data completeness - External data reconciliation - Site compliance trends - Contribute to study-level risk review meetings and cross-functional data review forums. - Support inspection readiness by maintaining documentation of centralized review activities and sponsor oversight. - Good working knowledge of ICH, FDA and GCP regulations and guidelines Qualifications - Bachelor’s degree in one of the life sciences, or equivalent knowledge and experience. - 2+ years of experience in biopharmaceutical industry or related field. - Proficiency with Medidata RAVE EDC system. - Experience in clinical data review. - Experience with sample management and supporting central lab, ECG, imaging, or other external vendor data reconciliation preferred. - Organized and thorough with attention to details. - Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results. - Natural collaborator who enjoys working on a cross-functional team.

Overview   Priovant is committed to developing therapies that address high unmet need in autoimmune disease. To support commercialization of our late-stage drug candidate, the CMC team is seeking an experienced manufacturing leader with deep small molecule expertise to provide strategic planning and operational oversight across our bulk product supply chain. The successful candidate will work directly with our external manufacturing partners, ensuring seamless product flow and robust commercial supply. The Senior Director, Commercial Manufacturing reports to the Senior Vice President, CMC. The position is remote, with domestic and international travel required as necessary to oversee activities at manufacturing partners, and to meet with the team periodically at our Durham, NC office. Responsibilities  - Strategically build and manage the commercial supply chain for small molecule pharmaceutical products, including starting materials, drug substance, and bulk drug product. - Work hands-on to seamlessly manage manufacturing operations at external suppliers, including contracting, scheduling of production to meet forecast demand, change control and deviation management, and issue escalation. - Lead product pricing negotiations, establish supply agreements, collaborate with legal to maintain relevant contracts, and manage the budget for bulk product manufacturing. - Partner with drug substance and drug product technical leads to expand production to additional sites as required to meet demand and globally minimize supply chain risk. - Collaborate with Regulatory to assure compliance of manufacturing activities with global regulatory requirements and filed product information. - Partner with Quality to author and implement relevant policies and operating procedures, maintain quality agreements, monitor for gaps, and establish appropriate mitigation strategies to ensure global product quality. Qualifications  - BS or BA in chemistry, chemical engineering, or related scientific discipline, with at least 12 years of small molecule manufacturing experience. - Top-tier expertise in managing external production networks for bulk pharmaceutical products, with a proven track record of working successfully with commercial manufacturing partners. - Detailed understanding of drug substance manufacturing, including the ability to review executed batch records, understand the impact of analytical test results, and manage deviations. - Ability to participate in complex commercial supply negotiations, critically review service agreements, and assure quality agreements align with operational goals. - Current knowledge of relevant global regulatory requirements that could impact production, testing, release, or distribution of products.

Overview   Priovant is committed to developing therapies that address high unmet need in autoimmune disease. To support the expansion of our supply chain, the CMC team is seeking an internal operations manager to actively organize project data and records, track materials, and streamline routine workflows. The role includes elements of documentation, operations, and project management, and requires continual engagement with all members of the CMC team, as well as with cross-functional and external partners. The Manager, CMC Operations reports to the Senior Vice President, CMC. The position is fully remote, with periodic travel required to meet with the team at our Durham, NC office. Responsibilities - Organize and continuously maintain our growing repository of CMC documentation to enable smoother operations, efficient authoring, and timely responses to regulatory agencies. - Partner with our legal and finance teams to facilitate contract approval, routing of invoices, and budget tracking. - Centrally manage inventories of non-commercial drug substance, bulk drug product, and reference materials. - Collaborate with Quality to develop coherent systems and directly manage routine quality events noted during manufacturing, shipping, and storage. - Coordinate internal review and approval of regulatory documentation. - Provide a vibrant central node of communication for a fully remote team and actively engage colleagues to drive timely completion of tasks. - Take initiative to identify pain points and inefficiencies within the team, and propose structural adjustments or modification of workflows to improve operations. Qualifications - Bachelor’s degree in a scientific or technical discipline. - Five years of hands-on CMC operational experience (drug substance, drug product, analytical) or equivalent experience providing direct support to CMC teams (project management). - Strong knowledge of CMC document types (manufacturing, analytical, quality) and basic understanding of CMC regulatory filing structure and content.