Global Safety Program Lead

Role Summary

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

Responsibilities

• Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications.
• Accountable for the 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 the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy.
• For the assigned asset(s), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset.
• Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, e.g., DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.
• Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s).
• Leads response to complex technical issues for specific safety aspects for the assigned asset(s).
• Is accountable for safety contribution to study designs and study concept delivery within their assigned program.
• Through integrated understanding of the product strategy, provides strategic safety knowledge and support to safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s).
• Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, literature for each asset.
• Ensures that own work and the work of the team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
• Represents the Company and accountable for the quality of safety delivery including regulatory submissions and responses to Health Authority Queries, Ethics Committees, investigators/sites, and provides clarifications as well as solves safety issues in the study team.
• May be required to support in-licensing opportunities.
• Promotes cross-functional, proactive and solutions-oriented team actions and behaviours.
• Accountable for the implementation of new processes, systems and learning, including new ways of working. Prioritizes risk mitigation strategies and effective trouble-shooting.
• Line-manages a team of safety physicians and/or scientists.
• Maintains up-to-date knowledge of relevant safety literature and communicates key information clearly; analyses clinical safety data to drive interpretations and inform labeling in global markets; serves as a scientific and clinical safety knowledge source for the Product Team.

Qualifications

• Required: 5 years extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities.
• Required: Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence to clinical studies/programs.
• Required: Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making (e.g., Clinical Development, Medical Affairs, Regulatory Affairs).
• Required: Thorough knowledge and understanding of pharmacovigilance and safety deliverables, standards and processes at a global level; including pre- and post-launch experience.
• Required: Experience of global regulatory submissions and interacting with major regulatory agencies.
• Required: Demonstrated ability to lead, coach, and mentor other safety medical directors/scientists.
• Required: Demonstrated ability to present complex topics to senior leaders at safety and development governances for alignment and endorsement.
• Preferred: PhD (or other complementary degree) in scientific discipline.
• Preferred: Excellent, independent judgment based on leading-edge knowledge and expertise.
• Preferred: Excellent speaking skills, industry conference speaking experience.
• Preferred: Demonstrated clinical safety and research expertise in an appropriate disease area.

Education

• Medical degree or equivalent degree in biomedicine or science

Additional Requirements

• Available to travel domestically and internationally