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

BioMarin Pharmaceutical Inc.; United States; Remote; USD 110,000 - 180,000; Full time

Job summary

BioMarin is seeking an IRT Lead to own the design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I–IV trials. This contract role sits at the intersection of Clinical Supply Chain, Global Study Operations, IT, and Supply Chain Strategy & Excellence, driving scale and efficiency in trial supply processes.

As an individual contributor, you will coordinate with internal teams and external vendors, ensure correct randomization and product handling, and lead

Qualifications

• Bachelor's degree in life sciences, engineering, supply chain, information systems, or a related field.
• Five or more years in clinical supply chain or clinical operations, with hands-on IRT/RTSM ownership across multiple concurrent studies.
• Demonstrated end-to-end delivery of IRT builds: specification, testing, go-live, study operations and support, change control, and close-out reconciliation.
• Working knowledge of randomization and blinding methodology, clinical demand forecasting, and IRT resupply algorithms.
• Experience managing external IRT vendors, including timelines, deliverables, quality, and escalation management.
• Familiarity with GCP, 21 CFR Part 11, computer system validation, and inspection readiness for clinical systems.
• Ability to work independently across global time zones and align cross-functional teams.

Responsibilities

• Serve as project manager for IRT on each assigned trial, leading study builds and support from kickoff through close-out.
• Translate protocols into URS, confirming randomization design, visit schedule, dosing regimens, stratification factors, unblinding rules, and drug supply configuration.
• Liaise with external IRT vendors, manage build timelines and deliverables, oversee study-specific modules against specifications.
• Develop test plans with IT and lead cross-functional UAT covering URS requirements, including drug resupply, reports, and integrations.
• Coordinate training and system access for site staff, monitors, and study teams, ensuring correct blinded/unblinded roles.
• Provide day-to-day oversight during trial conduct: monitor enrollment and inventory via IRT dashboards, troubleshoot issues with vendors and GSO.
• Represent CSC in cross-functional discussions and refine resupply parameters to minimize stock-outs and overages.
• Lead mid-study changes through formal change control, communicate with teams, and secure approvals and budgets before implementation.
• Lead IRT close-out with IT: lock database, reconcile IRT-EDC, archive data, and decommission systems.

Skills

IRT/RTSM ownership

Vendor management

Cross-functional coordination

Documentation & testing

GCP knowledge

Education

Bachelor's degree in life sciences or related field

Tools

EDC systems

CTMS

ERP systems

Job description

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 teams, verifying that blinded and unblinded roles are correctly assigned before first patient in.
• Provide day-to-day oversight during trial conduct: monitor enrollment and inventory through IRT dashboards, troubleshoot enrollment, dosing, and inventory issues with vendors and global study operations (GSO).
• Act as the Clinical Supply Chain (CSC) single point of contact for all IRT-related activities, representing CSC in cross-functional discussion. Continuously refine the IRT resupply parameters with Clinical Supply Chain (CSC) to prevent site stock-outs and reduce overages.
• Manage mid-study changes through formal change control process for protocol amendments by assessing cross-functional impact, updating specifications, retesting, and securing approvals and budget allocation before implementation, with clear communication to study teams and sites.
• Lead IRT close-out alongsideIT: database lock, IRT-to-EDC reconciliation, final investigational product accountability, data archival, and formal system decommissioning.

Portfolio Standards and Governance

• Own IRT and RTSM as a business process for the organization: maintain the standard operating procedures, work instructions, IRT standards, test scripts, and training materials, and fold lessons learned from each study back into them.
• Partner with the Head of Digital & Analytics in Supply Chain Strategy & Excellence to shape the IRT digital roadmap and its place in the wider Global Supply Chain (GSC) ecosystem. That group sets the operational framework; this role drives execution and surfaces mitigations where roadblocks appear.
• Define the multi-year direction for IRT capability, assessing emerging features such as platform integrations, direct-to-patient supply, drug pooling, and adaptive randomization, and building the case for those that measurably improve efficiency, patient experience, and/or data quality. Lead IRT vendor sourcing activities, including participation in RFQs/RFPs, vendor assessments, feasibility evaluations, and study-specific platform selection in partnership with Procurement, IT, and study teams. Also, run vendor governance: hold regular service reviews, monitor performance against agreed KPIs, and elevate issues. Commercial terms and change orders are shaped with Procurement and executed by BioMarin employees.
• Serve as the organization’s subject matter expert on IRT, coaching study teams and partnering with Clinical Operations on randomization and blinding design, Biostatistics and Data Management on data integration and validation, and IT and Quality Assurance on system validation and compliance.
• Define and report functional KPIs - system uptime, randomization error rate, site stock-out events, drug wastage - and turn IRT data into usable insight for senior management on supply performance, enrollment progress, and emerging trends.
• Represent IRT in cross-functional forums so that randomization and trial supply implications are weighed during protocol feasibility, risk management, and digital trial initiatives such as decentralized and adaptive designs.

Must haves: Minimum Required

• Bachelor's degree in life sciences, engineering, supply chain, information systems, or a related field.
• Five or more years in clinical supply chain, clinical operations, or clinical systems, including at least five years of hands-on IRT or RTSM ownership across multiple concurrent studies.
• Demonstrated end-to-end delivery of IRT builds: specification authoring, test leadership, go-live, study operations and support, mid-study change control, and close-out reconciliation.
• Working knowledge of randomization and blinding methodology, clinical demand forecasting, and IRT resupply algorithms.
• Proven experience managing external IRT vendors, including timeline, deliverables, quality, and escalation management.
• Familiarity with GCP, 21 CFR Part 11, computer system validation, and inspection readiness expectations for clinical systems.
• Ability to work independently across global time zones, with the judgment to elevate early and the communication skills to align functions that do not report to this role.

Nice to haves: Preferred

• Hands-on experience with more than one commercial IRT or RTSM platform.
• Rare disease, gene therapy, or global multi-region trial experience.
• Exposure to direct-to-patient supply models, decentralized trials, or adaptive designs.
• Experience with IRT integrations to EDC, CTMS, and ERP or supply planning systems.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.