Global Safety Program Lead

AstraZeneca•Gaithersburg, MD

2d•$221,630 - $332,435•Hybrid

About The Position

The Global Program Safety Lead is accountable to the Global Safety Head for safety strategy, delivery, and oversight for assigned assets or indications. The role works with safety physicians and scientists to develop, implement, and apply safety strategy at asset and study levels, while generating opportunities and value 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 in accordance with ethical, quality, compliance, regulatory, GxP, and AstraZeneca standards. The lead is accountable for scientific and clinical safety content, safety team goals, and implementation and quality delivery of safety management and surveillance teams. Responsibilities include safety input to product and study strategy and design, safety deliverables and regulatory submissions, risk management, safety data analysis and interpretation, and communication with governance bodies, health authorities, ethics committees, investigators, and other stakeholders. The role also maintains current knowledge of safety science and regulatory developments, collaborates with international colleagues and external partners, and supports cross-functional decision-making. The position is based in Gaithersburg. AstraZeneca’s stated working approach includes face-to-face office engagement three days per week, with flexibility to balance personal and work commitments. Domestic and international travel is required. The annual base pay range is $221,630 to $332,435, with eligibility for incentives. Benefits include qualified retirement programs, paid time off, and health, dental, and vision coverage.

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, biotech, CRO, academic, or health-authority setting.
Proven record of successful clinical safety delivery, including examples of strategic influence on clinical studies or programs.
Ability to collaborate in a matrixed environment and influence cross-functional leaders in areas such as Clinical Development, Medical Affairs, and Regulatory Affairs.
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 and scientists.
Ability to present complex topics to senior leaders at safety and development governance forums for alignment and endorsement.
Availability to travel domestically and internationally.

Responsibilities

Own the safety strategy, delivery, and oversight for assigned assets or indications, reporting to the Global Safety Head.
Lead the scientific and clinical safety content for assigned assets or indications and align safety team goals with therapeutic-area and product strategy.
Implement and ensure high-quality delivery of the Safety & Strategy Management Team and Safety Surveillance Team for assigned assets.
Own safety target product profiles, safety Go/No-Go criteria, safety communications and messaging, and toxicity-management guidelines.
Represent Global Patient Safety at governance forums, product teams, and advisory board meetings, in partnership with the Global Safety Head.
Ensure quality of safety deliverables, including Risk Management Plans and Periodic Safety Reports, and compliance with pharmacovigilance regulations.
Lead responses to complex technical issues related to safety for assigned assets.
Provide safety input to study designs and study concepts, and support program design, monitoring, and data interpretation across preclinical and clinical programs.
Lead safety physicians and scientists in safety strategy, clinical program support, safety communications, and post-marketing surveillance.
Ensure own and team work complies with Safety, Health and Environment standards and other applicable internal and external regulations.
Represent the company and ensure quality of safety contributions to regulatory submissions, health authority queries, ethics committees, marketing companies, investigators, and study teams.
Support in-licensing opportunities when required.
Promote cross-functional, proactive, solutions-oriented collaboration and implement new processes, systems, learning, and ways of working.
Prioritize risk-mitigation strategies and effective troubleshooting.
Line manage, coach, and support a team of safety physicians and/or scientists.
Maintain current knowledge of relevant safety literature and communicate impactful information.
Ensure appropriate safety data collection and interpretation to determine risks and inform global product labeling.
Deliver balanced, statistically robust analyses of clinical safety data and develop proposals based on the findings.
Serve as a source of scientific and clinical safety expertise for product teams analyzing and interpreting safety data.
Maintain awareness of emerging global clinical safety developments and build global networks with international colleagues and external alliance partners.
Provide safety guidance for investigator-initiated trials in cooperation with regional marketing companies when required.
Travel domestically and internationally.