(CW) Sr. Manager, Interactive Response Technology ,Clinical Trials (CONTRACT-REMOTE)

Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
CONTRACT_ REMOTE DURATION 1 YEAR PLUS
BioMarin is engaging a hands-on Interactive Response Technology (IRT) Lead to own the design, build, implementation, and lifecycle management of IRT/RTSM (randomization and trial supply management) systems across Phase I–IV clinical trials, including the integrations that connect them to adjacent clinical and enterprise platforms.
This is an individual contributor engagement: the person in this seat does the work, rather than directing a team that does it.
The role sits at the intersection of Clinical Supply Chain, Global Study Operations, IT, and Supply Chain Strategy & Excellence, and carries end-to-end responsibility for IRT across the trial portfolio. Day to day, that means making sure patient randomization and investigational product handling run cleanly at the study level. Over the course of the engagement, it also means raising the standard — building the templates/standards, governance routines, and best practices that let IRT scale beyond any single trial. Success depends as much on cross-functional influence as on technical depth.
This is a contract position. The IRT Lead partners closely with internal stakeholders and external vendors, but does not manage BioMarin employees.
Responsibilities:
Study-Level Execution
• Serve as project manager for IRT on each assigned trial, leading study builds and support from kickoff through close-out, and holding both the vendor and the internal team to the study timeline.
• Partner with IT and study teams to translate protocols into User Requirement Specifications (URS), confirming that the randomization design, visit schedule, dosing regimens, stratification factors, unblinding rules, and drug supply configuration are captured accurately before the build begins.
• Act as the primary liaison to external IRT vendors, managing build timelines and deliverables, and overseeing configuration of study-specific modules against the approved specification. Also manage the internal study team to ensure adherence to the same build timelines and deliverables.
• Develop test plans with IT and orchestrate cross-functional User Acceptance Testing (UAT) covering all requirements defined in the URS, including drug resupply, reports, and system integrations, with every defect documented and resolved before go-live.
• Coordinate training and system access for site staff, monitors, and study team