Global Safety Head

About This Role

The Global Safety Head is the most senior safety expert reporting to the Global Patient Safety Therapeutic Area Head Oncology, accountable for all safety aspects of assigned assets in Oncology. This role involves setting safety goals, leading project-specific safety strategies, and managing a team of Global Safety Program Leaders to ensure patient safety quality and compliance across the product lifecycle.

Responsibilities

• Set safety goals aligned to TA and asset strategy
• Lead project-specific safety strategy and contribute to overall asset strategy
• Assure required patient safety quality and compliance in all activities
• Line manage a team of Global Safety Program Leaders, safety physicians, and/or scientists
• Drive staff development and performance in support of AZ products
• Act as single point accountable leader for the safety strategy of assigned assets throughout their lifecycle
• Ensure the ethical and scientific integrity of the safety component of plans, studies, and products
• Represent Global Patient Safety at governance and other forums where safety is involved
• Accountable for scientific and clinical strategies for safety components of TPP, TPC, CDP, and core labelling
• Act as lead safety representative for assigned assets in regulatory interactions and internal senior governance bodies

Requirements

• Medical degree or equivalent in biomedicine or science
• 8+ years clinical, safety, and risk management experience in pharmaceutical, biotech, CRO industry, academia or Health Authorities
• Direct experience with global regulatory filing and interacting with major regulatory agencies (e.g., FDA advisory Committees, Scientific Advice)
• Knowledge of relevant pharmacovigilance legislation and GxP requirements
• Thorough knowledge and understanding of safety, including clinical safety, deliverables, standards and processes at a global level (pre and post launch experience)
• Proven track record of successful clinical safety delivery with strategic influence to portfolio/clinical studies/programs
• Ability to navigate a matrixed environment and influence cross-functional senior leaders on decision-making
• Sound problem solving skills with ability to make decisions by developing innovative options/multiple solutions to complex problems
• Demonstrated ability to successfully lead, coach, and mentor all safety team members
• Proven teamwork and collaboration skills in a global setting
• Strong personal time-management, project-management and organizational skills
• Excellent presentation skills and effective communication with internal and external collaborators
• Results-driven leader to foster proactive solutions
• Sound judgment to filter information and weigh multiple factors for patient product safety decisions
• Demonstrated ability to motivate, influence and collaborate with others in a complex global organizational matrix
• Available to travel domestically and internationally
• Demonstrated ability to present complex topics to senior leaders at governances for alignment and endorsement
• Knowledge and understanding of US and EU safety regulations pre- and post- marketing

Qualifications

• Medical degree or equivalent degree in biomedicine or science
• Minimum of 8 years or equivalent extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities

Nice to Have

• PhD (or other complementary degree) in scientific discipline
• Clinical Development and / or Regulatory and / or Medical Affairs experience
• Excellent, independent judgment based on leading-edge knowledge and expertise
• Industry conference speaking experience
• Demonstrated clinical safety and research expertise in an appropriate disease area

Benefits