Global Safety Program Lead

Location: Gaithersburg, MD | Posted: 16-Oct-2026 | Closes: 30-Oct-2026

About the role

The Global Program Safety Lead is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of assigned asset(s). The role holder works with safety physicians and scientists responsible for the development, implementation, and application of safety strategy at asset and study level, acting strategically to generate opportunity and value for the asset or indication to optimize benefit-risk and maintain competitive advantage. The position line manages a team of safety physicians and/or scientists and may deputise for the Global Safety Head. The individual operates according to the highest ethical, quality, and compliance standards in accordance with global and local regulations, GxP practice, and AstraZeneca procedures.

Responsibilities

• Accountable for overall scientific and clinical safety content for assigned asset(s) or indications
• Accountable for implementation and high-quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s)
• Responsible for overall safety content for product or indication(s) aligned to Global Product Team (GPT) strategy
• Sets safety team goals aligned to Therapeutic Area and product strategy
• Accountable for safety Target Product Profile (TPP), Safety Go/No-Go criteria, safety communication/messaging, and guidelines for toxicity management of the asset
• Accountable for project representation for Global Patient Safety at governance forums (e.g., DRC, eCRC, SARB, FSIRB, DSMB/DMC, Medical Affairs Review Committees, CPT, GPT, Advisory Board meetings) in partnership with Global Safety Head
• Accountable for quality of key safety deliverables (Risk Management Plans, Periodic Safety Reports), compliance and adherence to pharmacovigilance regulations for assigned asset(s)
• Leads response to complex technical issues for specific safety aspects for assigned asset(s)
• Accountable for safety contribution to study designs and study concept delivery within assigned program
• Provides strategic safety knowledge and support to safety medical directors and scientists through initiation, execution, and completion of clinical programs for assigned asset(s)
• Leads safety physicians and scientists to support safety strategy and input into program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature review
• Ensures own work and team work complies with Safety Health and Environment (SHE) standards and all relevant internal and external regulations
• Represents the Company and is accountable for quality of safety delivery (regulatory submissions, Health Authority Query responses, Ethics Committees, Marketing Companies, investigators/sites) and provides clarifications and solves safety issues in study teams
• May support in-licensing opportunities
• Promotes and enables cross-functional, proactive, solutions-oriented team actions and behaviours
• Accountable for implementation of new processes, systems, and learning, including new ways of working
• Prioritizes risk mitigation strategies and effective troubleshooting
• Line manages a team of safety physicians and/or scientists
• Maintains up-to-date knowledge of relevant safety scientific literature and clearly communicates key impactful information
• Accountable for proper data collection and interpretation for risk determination and global labeling
• Delivers analyses of clinical safety data in a balanced, statistically robust manner to drive interpretations and develop novel proposals
• Serves as source of scientific and clinical safety knowledge for Product Team in analyses and interpretation of safety data
• Maintains high awareness of new and emerging clinical safety developments globally
• Maintains strong global networks and works with international colleagues and external alliance partners on safety initiatives and regulatory issues
• Provides safety guidance for investigator-initiated trials in cooperation with regional marketing companies when required

Requirements

• Medical degree or equivalent degree in biomedicine or science
• 5+ years extensive relevant clinical, safety, and risk management experience in pharmaceutical, biotech, CRO industry, academia, or Health Authorities
• Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence to clinical studies/programs
• Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making (Clinical Development, Medical Affairs, Regulatory Affairs)
• Thorough knowledge and understanding of pharmacovigilance & safety deliverables, standards, and processes at a global level; including pre- and post-launch experience
• Experience of global regulatory submissions and interacting with major regulatory agencies
• Demonstrated ability to successfully lead, coach, and mentor other safety medical directors/scientists
• Available to travel domestically and internationally
• Demonstrated ability to present complex topics to senior leaders at safety and development governances for alignment and endorsement

Pay

The annual base pay for this position ranges from $221,630 to $332,435. Positions offer eligibility for various incentives — short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits

• Qualified retirement programs
• Paid time off (vacation, holiday, and leaves)
• Health, dental, and vision coverage in accordance with applicable plan terms