Global Safety Program Lead

AstraZeneca • Gaithersburg, MD

1d • $288,059 - $432,089

About The Position

The Global Safety Program Lead is accountable to the Global Safety Head for safety strategy, delivery, and oversight for assigned assets or indications. The role partners with safety physicians and scientists to develop, implement, and apply safety strategy at asset and study level, and works strategically to optimize benefit-risk and maintain competitive advantage. The position line manages safety physicians and/or scientists and may deputize for the Global Safety Head. The role operates according to high ethical, quality, and compliance standards, including global and local regulations, GxP practice, and company procedures.

The role provides overall scientific and clinical safety leadership for assigned assets, including safety team strategy and goals, safety content, safety deliverables, regulatory compliance, study design contributions, and interpretation of preclinical and clinical data. It represents Global Patient Safety at governance and other forums, leads responses to complex safety issues, and supports regulatory submissions and communications with health authorities, ethics committees, investigators, and other stakeholders. The lead also supports cross-functional collaboration, risk mitigation, process implementation, and development of team members.

The role maintains current knowledge of safety literature and emerging clinical safety developments, interprets safety data to inform global labeling and risk management, and builds international and external safety networks. It may provide safety guidance for investigator-initiated trials and support in-licensing opportunities. The job description notes that other job-related duties may be assigned.

Requirements

• Medical degree or equivalent degree in biomedicine or science.
• At least 5 years of extensive relevant clinical, safety, and risk management experience in the pharmaceutical, biotechnology, CRO, academic, or health authority sector.
• Proven record of successful clinical safety delivery, with examples of strategic influence on clinical studies or programs.
• Ability to collaborate in a matrixed environment and influence cross-functional leaders in decision-making.
• Thorough global knowledge of pharmacovigilance and safety deliverables, standards, and processes, including pre-launch and post-launch experience.
• Experience with global regulatory submissions and interactions with major regulatory agencies.
• Demonstrated ability to lead, coach, and mentor safety medical directors or scientists.
• Availability to travel domestically and internationally.
• Demonstrated ability to present complex topics to senior leaders at safety and development governance forums.

Nice To Haves

• PhD or another complementary degree in a scientific discipline.
• Excellent independent judgment based on leading-edge knowledge and expertise.
• Excellent speaking skills and experience speaking at industry conferences.
• Demonstrated clinical safety and research expertise in an appropriate disease area.

Responsibilities

• Set and oversee safety strategy, delivery, and oversight for assigned assets or indications.
• Provide overall scientific and clinical safety content for assigned assets and indications.
• Implement and ensure high-quality delivery of Safety & Strategy Management Teams and Safety Surveillance Teams for assigned assets.
• Set safety team goals aligned with therapeutic area and product strategy.
• Oversee safety target product profiles, Safety Go/No Go criteria, safety communications and messaging, and toxicity management guidelines.
• Represent Global Patient Safety at governance forums and product-team meetings, in partnership with the Global Safety Head where applicable.
• Ensure quality of safety deliverables, including Risk Management Plans and Periodic Safety Reports, and compliance with pharmacovigilance regulations.
• Lead responses to complex technical issues involving safety aspects of assigned assets.
• Contribute safety expertise to study design and study concept delivery.
• Provide strategic safety support throughout initiation, execution, and completion of clinical programs.
• Lead safety physicians and scientists in safety strategy and input to program design, monitoring, data interpretation, communications, and post-marketing surveillance.
• Ensure team work complies with Safety, Health and Environment standards and other applicable regulations and standards.
• Represent the company and oversee safety delivery for regulatory submissions and responses to health authorities, ethics committees, marketing companies, and investigators or sites; clarify and resolve study-team safety issues.
• Support in-licensing opportunities when required.
• Promote cross-functional, proactive, solutions-oriented team actions and behaviors.
• Oversee implementation of new processes, systems, learning, and ways of working.
• Prioritize risk mitigation strategies and effective troubleshooting.
• Line manage, coach, and mentor safety physicians and/or scientists.
• Maintain current knowledge of relevant safety literature and communicate impactful findings.
• Oversee appropriate collection and interpretation of data to determine risks and inform global product labeling.
• Deliver balanced, statistically robust analyses of clinical safety data to develop interpretations and proposals.
• Serve as a source of scientific and clinical safety expertise for product teams.
• Maintain awareness of emerging global clinical safety developments and build international and external networks.
• Work with international colleagues and external alliance partners on safety initiatives and regulatory issues.
• Provide safety guidance for investigator-initiated trials in cooperation with regional marketing companies when required.
• Travel domestically and internationally.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.
• Eligibility for a retirement contribution for hourly roles.
• Commission payment eligibility for sales roles.
• Qualified retirement program, including a 401(k) plan.
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior