BioMarin Pharmaceutical Inc.

Manager

• Own the design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I–IV clinical trials
• Manage integrations connecting IRT/RTSM systems to adjacent clinical and enterprise platforms
• Serve as project manager for IRT on assigned trials from kickoff through close-out
• Translate protocols into User Requirement Specifications covering randomization, visit schedules, dosing regimens, stratification, unblinding, and drug supply configuration
• Liaise with external IRT vendors and manage study build timelines, deliverables, and configuration
• Develop test plans and lead cross-functional User Acceptance Testing
• Coordinate training and system access for site staff, monitors, and study teams
• Monitor enrollment and inventory through IRT dashboards and troubleshoot trial issues
• Serve as Clinical Supply Chain's single point of contact for IRT activities
• Refine IRT resupply parameters to prevent site stock-outs and reduce overages
• Manage protocol-amendment changes through formal change control
• Lead IRT close-out, including database lock, IRT-to-EDC reconciliation, product accountability, archival, and decommissioning
• Maintain IRT/RTSM procedures, work instructions, standards, test scripts, and training materials
• Shape the IRT digital roadmap and multi-year capability direction
• Lead IRT vendor sourcing, assessments, platform selection, and governance
• Serve as the organization's IRT subject matter expert and coach cross-functional teams
• Define and report functional KPIs such as system uptime, randomization error rate, stock-outs, and drug wastage
• Represent IRT in protocol feasibility, risk management, and digital trial initiatives

Senior Manager, Interactive Response Technology, Clinical Trials

Director

• Serve as a technical quality expert for one or more products during clinical development through post-commercialization
• Make technical quality-related decisions and serve as the CMC team’s single point of contact for quality functions, risks and issues
• Provide quality leadership for CMC-related strategic activities and drive quality decisions
• Participate in CMC team meetings and technical forums, providing expertise for global strategies and implementation plans across the product lifecycle
• Partner with CMC and Quality teams to identify, develop and prioritize long-term product strategies and initiatives
• Create product-specific Quality strategies
• Lead the cross-functional Quality Partner Team and manage deliverables aligned with CMC execution plans
• Communicate relevant information between the Quality Partner Team, CMC Team and functional managers
• Own and manage the product quality risk register, including issue identification, resolution, mitigation and escalation
• Develop phase-appropriate product specifications and collaborate on the Quality Target Product Profile and product control strategy
• Develop product comparability protocols and assessments for clinical-stage and commercial products
• Interpret and apply regulatory guidelines and directives including 21 CFR, USP, EP, JP and ICH
• Review and author regulatory submission sections
• Review and approve Annual Product Reviews for commercial programs
• Oversee and monitor CMC-related Health Authority commitments
• Support or lead initiatives to improve PQL operational efficiency and effectiveness
• Lead cross-portfolio initiatives to reduce technical quality risks

Director, Product Quality Leader

Account Manager

• Maximize sales of BioMarin commercialized products in the assigned area
• Achieve quarterly and annual territory sales, penetration, market share, and profit targets
• Create and implement business plans covering strategy, disease awareness, patient compliance, and progress tracking
• Create and execute individual institutional plans within specific networks of care
• Maintain relationships with neurologists, pediatric neurologists, epileptologists, geneticists, nurses, nurse practitioners, genetic counselors, physicians, and institutional staff
• Communicate with external customers and internal stakeholders in person and through internet-based platforms
• Provide leadership by example to fellow Institutional Account Managers
• Financially manage the assigned territory
• Participate in business planning meetings, disease awareness efforts, and professional society meetings
• Become an expert in CLN2 and MPS data and explain its significance
• Provide field insight to internal business partners regarding assigned accounts’ clinical practices
• Demonstrate leadership and influence without authority within internal teams
• Follow company compliance requirements and policies

Institutional Account Manager

Supply Chain

• Lead enterprise planning across demand, supply, inventory, capacity, and financial objectives through Integrated Business Planning (IBP)
• Drive profitable growth, operational agility, and patient-centric outcomes across a global rare disease supply network
• Own the global IBP framework and maintain the IBP cadence across product, demand, supply, reconciliation, and executive reviews
• Own the S&OE process and align near-term demand, supply, and inventory decisions with the broader IBP framework
• Integrate clinical and commercial planning across shared supply sources and manufacturing assets
• Oversee reconciliation of commercial, patient, named-patient, early-access, and clinical trial demand signals
• Lead inventory management, risk-based scenario planning, and supply resilience initiatives
• Chair cross-functional IBP forums and establish governance and decision rights
• Lead and develop the Integrated Planning & Analytics team through mentoring, performance goals, feedback, and training
• Partner with Finance on AOP/LRP cycles, operational and financial planning, portfolio integration, and strategic investment business cases
• Lead long-range capacity planning and modeling for future portfolio growth and patient demand
• Define the IBP technology vision with Digital/IT and ensure data quality for critical planning attributes
• Lead data analytics, dashboards, advanced planning insights, and risk-based scenario evaluation
• Drive adoption of IBP behaviors, build planning capability, and mentor global and regional planners
• Serve as an internal expert and thought leader on best-practice IBP/S&OP for rare disease and biologics

Senior Manager, Interactive Response Technology, Clinical Trials

Director, Product Quality Leader

Institutional Account Manager

Senior Director, Integrated Planning & Analytics – Global Supply Chain