Senior Medical Director in Safety Science

About the role

The Senior Medical Director in Safety Science will lead the safety science efforts for a novel therapeutic area within BioMarin. Reporting to the Head of Safety Science, this role will oversee the safety assessment and management of clinical trials, ensuring compliance with regulatory requirements and fostering a culture of safety across the organization.

Responsibilities

• Oversee the safety science aspects of clinical trials, including risk assessment, monitoring, and reporting
• Develop and maintain robust safety databases and systems to support data analysis and decision-making
• Collaborate with cross-functional teams to ensure alignment on safety strategies and protocols
• Provide expert guidance on safety issues and regulatory requirements to project teams
• Lead the safety science team in conducting regular safety reviews and providing feedback to clinical teams
• Ensure compliance with regulatory guidelines and standards, such as ICH E2A, E2B, and E2C

Requirements

• Doctorate/PhD in a relevant field (e.g., Pharmacology, Toxicology, Medicine)
• At least 10 years of experience in pharmaceutical safety, clinical research, or related field
• Proven track record in managing safety science activities in clinical trials
• Experience with regulatory submissions and interactions with regulatory agencies
• Strong leadership skills and ability to manage a team
• Excellent communication and collaboration skills

Qualifications

• Expertise in pharmacokinetics, toxicology, and clinical trial design
• Knowledge of regulatory frameworks and guidelines (ICH, FDA, EMA)
• Experience with statistical analysis and data interpretation
• Ability to manage multiple projects simultaneously and meet deadlines

Skills

• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Proficiency in Microsoft Office Suite
• Ability to work independently and as part of a team

Benefits

• Competitive salary commensurate with experience
• Flexible working arrangements, including remote work options
• Comprehensive health insurance coverage
• Retirement savings plan with employer match
• Professional development opportunities

Pay

• $200,000 - $250,000 annually

Schedule

• Full-time, remote position