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 Corporate Groups

It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.

Role Overview

The Director, Enterprise Risk, Investigations & Remediation leads core elements of the US Corporate Compliance program focused on risk detection, internal investigations, remediation, and oversight of high-risk business activities, including advisory boards, speaker programs, and patient services. 

This role is responsible for managing hotline matters and leading internal investigations, including ownership of the investigation case management system and end-to-end intake process, supporting enterprise and business unit risk assessments, translating monitoring and investigation findings into practical remediation plans, and developing risk reporting that supports leadership decision-making.

The ideal candidate is a strong compliance operator and trusted cross-functional leader who can influence enterprise-wide compliance priorities, advise senior leadership on emerging risks, and ensure sustainable risk-based compliance frameworks that enable the business while protecting the organization. 

Key Responsibilities

Enterprise Risk Management & Risk Assessments

• Lead and coordinate US business unit risk assessment activities, including risk identification, prioritization, documentation, and follow-up planning.
• Lead risk budget inputs and cross-functional risk discussions to ensure resources are aligned to evolving compliance priorities.
• Identify emerging risk themes from investigations, monitoring, hotline activity, business initiatives, audits, and external enforcement trends.
• Present significant risk matters, investigation trends, remediation effectiveness, and emerging risk assessments to executive leadership and Compliance Committee audiences.

Internal Investigations & Hotline Management

• Lead day-to-day hotline intake, triage, investigation planning, execution, documentation, and reporting for US Corporate Compliance matters.
• Lead investigations involving potential violations of healthcare compliance requirements, company policies, or expected business conduct.
• Partner with Legal, HR, business stakeholders, and relevant control functions to ensure appropriate investigation scope, factual development, stakeholder engagement, and escalation.
• Prepare clear investigation summaries, findings, recommendations, and leadership updates that are appropriately calibrated to the sensitivity and complexity of the matter.
• Identify repeat issues, root causes, and potential systemic concerns requiring broader remediation, training, control enhancement, or governance attention.
• Own the investigation system, interface, and look/feel, along with the end-to-end process for managing intake, categorization, workflow, and case tracking, in accordance with governing investigation guidelines; partner with IT and vendors to configure, maintain, and continuously improve the platform as program needs evolve.

Remediation Leadership & Corrective Action Effectiveness

• Lead root cause analysis and remediation planning for investigation, monitoring, audit, and risk assessment findings.
• Develop practical corrective action plans, including control enhancements, process redesign, role clarifications, training reinforcement, communications, and follow-up monitoring where appropriate.
• Track remediation status, owners, timing, and effectiveness to ensure risks are addressed and sustained improvements are achieved.
• Partner with the Global Monitoring lead and Compliance Training lead to translate findings into monitoring priorities, training content, job aids, and targeted reinforcement.

Patient Services Oversight & Hub Risk Integration

• Provide compliance oversight for patient services and hub-related activities, including new patient support initiatives, patient meal and interaction limits and promotional-item approval requirements, and operational changes that may raise healthcare compliance risk.
• Develop or refresh monitoring, training, and policy strategies for patient services activities in partnership with relevant business and control stakeholders.
• Assess patient support initiatives for risk patterns, process gaps, role clarity issues, and opportunities for governance or control enhancement.
• Escalate significant or recurring patient services risks to Compliance leadership and support corrective action planning.

Advisory Boards, Speaker Programs & High-Risk Activity Oversight

• Lead compliance governance support for advisory board and speaker program risk areas, including setting standards, fair market value exception approvals, providing input into monitoring strategy, repeat issue identification, and trend analysis.
• Partner with Commercial, Medical, Legal, and operations stakeholders to assess advisory board processes and identify opportunities to strengthen controls, documentation, training, and accountability.
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• Provide targeted risk support on high-risk initiatives and escalated business counseling matters requiring deeper compliance analysis.

Compliance Analytics, Dashboards & Leadership Reporting

• Lead development of dashboards and risk reporting for compliance, hotline, investigation, monitoring, remediation, and other relevant metrics.
• Prepare quarterly leadership reporting and Compliance Committee materials, translating data into concise insights, themes, and action-oriented recommendations.
• Use analytics, including data-driven and, where appropriate, AI-enabled tools, to identify risk trends, repeat issues, potential control gaps, and areas for proactive business engagement.
• Develop materials and strategic recommendations for senior leadership and Board-level compliance oversight activities. 
• Ensure executives have visibility into key risk trends, investigation outcomes, and remediation effectiveness.
• Provide strategic recommendations regarding risk tolerance, resource allocation, and compliance investments to senior leadership.

Monitoring Liaison, Audit Support & Cross-Functional Governance

• Partner with the Global Monitoring lead on reviews by providing risk input, reviewing findings, identifying themes, and supporting appropriate follow-up.
• Support compliance audits and related follow-up activities as needed.
• Participate in cross-functional governance forums and strategic risk reviews to represent compliance risk insights and remediation priorities.
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Qualifications

Education

• Bachelor’s degree required.
• J.D., advanced degree, or specialized certification (e.g., Certified in Healthcare Compliance (CHC), Certified Fraud Examiner (CFE), or similar) preferred.

Experience

• 8-12 years of experience in pharmaceutical, biotech, healthcare compliance, legal, investigations, audit, risk management, or regulatory roles.
• Experience conducting or managing internal investigations and developing remediation plans preferred.
• Experience with healthcare compliance risk areas such as HCP engagements, advisory boards, speaker programs, HCP payments/transparency reporting, promotional practices, patient services, field activities, Medical Affairs, or Commercial operations required.
• Experience developing dashboards, metrics, reports, or risk insights for leadership audiences preferred.
• Experience owning or partnering with IT and vendors on compliance case management, hotline, or monitoring technology platforms preferred.

Key Capabilities & Attributes

• Strong judgment, discretion, and maturity in handling sensitive matters and escalations.
• Ability to lead investigations, identify root causes, and drive balanced, practical remediation.
• Strong analytical mindset with the ability to connect data, findings, and business context into actionable risk insights.
• Excellent written communication skills, including concise investigation summaries, risk analyses, and leadership-ready materials.
• Ability to influence cross-functional stakeholders without authority and drive accountability for corrective actions.
• Strong project management skills, with the ability to manage multiple matters, deadlines, stakeholders, and workstreams independently.
• Practical understanding of healthcare compliance requirements and ability to apply them in a business-relevant manner.
• Collaborative, calm, and credible presence in complex or sensitive situations.
• Comfort owning and improving compliance systems and technology and partnering with IT and outside vendors to translate business and regulatory needs into practical system design.

What Will Make Someone Successful in This Role

• Is trusted to own sensitive investigations, risk matters, and the systems and processes that support them, with independence, judgment, and appropriate escalation.
• Turns findings into practical remediation that improves controls and reduces repeat issues.
• Uses data and trends to help the organization see risk earlier and respond more effectively.
• Builds strong relationships with Legal, HR, Commercial, Medical, Patient Services, monitoring, training, and business stakeholders.
• Communicates clearly and constructively, including when delivering difficult messages or driving accountability.
• Maintains role clarity by leading enterprise risk, investigations, remediation, and high-risk oversight while partnering with the Sr. Manager business partner on day-to-day BU support.

 
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.