Senior Manager, RTSM Lead, Clinical Supply & External Manufacturing

Introduction to role: Are you ready to lead the systems that keep clinical trials supplied, blinded, and on time? As Senior Manager, RTSM Lead, you will shape how we design and run IRT/RTSM across global studies, translating standards into practice and vendor partnerships into reliable delivery. Based in Boston, you will sit at the heart of our clinical supply ecosystem, making sure every site gets the right medicine for the right patient at the right moment. Your work will safeguard data integrity and patient safety while shortening study timelines for people living with rare and devastating conditions. You will guide cross-functional teams, elevate quality through robust UAT and governance, and bring best-in-class solutions into our operating model. How will you use your expertise to unlock smarter, faster trials that reach under-served patients sooner? Accountabilities: • RTSM Leadership and Delivery: Lead cross-functional, global study teams in the end-to-end set-up, delivery, maintenance, and archival of RTSM as the subject matter expert, ensuring systems are delivered to study timelines and needs. • Vendor Partnership and Standards: Coordinate and manage the RTSM vendor to deliver against timelines and standards in line with regulatory requirements; drive the implementation of RTSM standards and best practices; contribute to internal governance and vendor oversight. • User Acceptance and Quality: Plan and execute UAT, including authoring test plans, coordinating vendor support, and preparing study teams, to ensure right-first-time deployments and continuous monitoring. • Issue Management and Escalation: Serve as the study-level point of escalation for RTSM issues and ensure effective and timely resolution through established pathways. • Documentation and Budget Stewardship: Own required documentation as defined in the TMF and the team playbook; manage RFP processes and study-level RTSM budgets to ensure clarity, control, and value. • Continuous Improvement and Innovation: Participate in and lead improvement initiatives focused on RTSM; identify, assess, and help onboard best-in-class RTSM solutions to strengthen clinical supply operations. • Compliance and Inspection Readiness: Support audits and regulatory inspections; uphold blinding controls and data integrity across study operations to meet GxP and regulatory expectations. Essential Skills/Experience: • Minimum of three to five years of experience in the biopharmaceutical industry with focus on RTSM study support. • End-to-end RTSM systems experience including set-up, implementation, and closeout of RTSM systems as well as issue management and vendor oversight. • Experience with various trial/study designs across different therapeutic areas and the operational knowledge of maintaining blinding controls and data integrity. • Strong understanding of RTSM, GCP, GMP and applicable regulatory requirements. • Demonstrated project management and process improvement skills including excellent planning, organizational, and analytical skills. • The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. Desirable Skills/Experience: • 5+ years of RTSM experience within biopharma industry with at least 3 years of managing complex studies and/or projects • Bachelor’s degree, MBA, or equivalent level of experience • Business process mapping experience preferred • Excellent written and verbal skills and s