Head of Safety Science

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

ROLE SUMMARY

The Head of Safety Science provides executive leadership for BioMarin's global pharmacovigilance and safety science operations, establishing the strategic direction for safety across the entire product portfolio. This role drives innovative approaches to safety science, ensures regulatory compliance, and serves as a medical authority for benefit-risk decisions. You will lead a team of safety professionals while partnering with the Global Head of Pharmacovigilance and R&D executives to integrate safety considerations into overall business strategy.

KEY RESPONSIBILITIES

Strategic Leadership

• Establish the overarching safety strategy for BioMarin's product portfolio, aligning with corporate objectives.
• Drive innovation in pharmacovigilance methodologies, leveraging advanced analytics and real-world evidence.
• Lead the evaluation and implementation of artificial intelligence and machine learning technologies to enhance safety signal detection, benefit-risk evaluation, and pharmacovigilance operations.
• Lead the development of global safety governance frameworks and decision-making processes.
• Represent safety interests at the executive leadership level, influencing corporate strategy.
• Foster a culture of patient-centric safety stewardship across the organization.

Regulatory Excellence

• Serve as principal safety expert in high-stakes regulatory interactions and negotiations.
• Oversee regulatory strategy for safety-related submissions and communications.
• Lead preparation for regulatory inspections and critical authority meetings.
• Anticipate and prepare for evolving global pharmacovigilance regulations.
• Develop strategic approaches to complex benefit-risk challenges.

Organizational Development

• Build and develop a world-class team of safety physicians, scientists, and pharmacovigilance professionals.
• Mentor Senior Medical Directors and safety leadership team members.
• Drive cross-functional collaboration between Safety Science and other departments.
• Manage departmental resources, budget, and strategic planning.
• Create career development pathways for safety science professionals.

Scientific Advancement

• Champion innovative approaches to safety signal detection and evaluation, including artificial intelligence, machine learning, and advanced analytics.
• Represent BioMarin in industry groups and scientific forums on pharmacovigilance.
• Drive publication strategy for safety-related research and methodologies.
• Forge partnerships with academic institutions and industry consortia.
• Advance the integration of genomics, biomarkers, and digital health into safety science.

QUALIFICATIONS

Education and Experience

• MD/PhD or equivalent advanced medical/scientific degree required.
• 15+ years of pharmaceutical industry experience with 10+ years in pharmacovigilance leadership.
• Extensive experience interacting with global regulatory authorities at senior levels.
• Track record of successfully leading safety through product approvals and post-marketing periods.

Technical Knowledge

• Expert understanding of global pharmacovigilance regulations and requirements.
• Deep knowledge of advanced pharmacovigilance methodologies and benefit-risk frameworks.
• Strong grasp of clinical development, regulatory affairs, and medical affairs functions.
• Understanding of quantitative methods for safety data analysis and interpretation.
• Demonstrated ability to translate complex safety concepts for diverse stakeholders.

Leadership Capabilities

• Exceptional team building and organizational development skills.
• Strategic vision and ability to navigate complex organizational dynamics.
• Strong business acumen and resource management capabilities.
• Excellent communication and presentation skills at executive and board levels.
• Proven ability to drive innovation while maintaining regulatory compliance.

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.