Global Safety Program Lead

AstraZeneca•Gaithersburg, MD

1d•Hybrid

About The Position

The Global Program Safety Lead is accountable to the Global Safety Head for safety strategy, delivery, and oversight of assigned assets or indications. The role works with safety physicians and scientists to develop and implement safety strategy at the asset and study levels, and acts strategically to optimize benefit-risk and maintain a 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, global and local regulatory, GxP, and AstraZeneca standards. The lead owns the scientific and clinical safety content for assigned assets, including safety strategy, team goals, safety target product profiles, Go/No Go criteria, safety messaging, toxicity-management guidance, and safety input to study design and clinical program delivery. The role represents Global Patient Safety at governance forums and product-team and advisory-board meetings, and is accountable for the quality of safety deliverables, including risk management plans, periodic safety reports, regulatory submissions, and responses to health authority queries. The lead supports safety analysis and interpretation across preclinical and clinical studies, communications, post-marketing surveillance, epidemiology, and literature, and may support in-licensing opportunities and investigator-initiated trials. The position also maintains current knowledge of relevant safety literature and emerging clinical safety developments, develops global networks and external partnerships, and leads, coaches, and mentors safety colleagues. The role is based in Gaithersburg, with employees expected to work face-to-face in the office three days per week. Domestic and international travel is required.

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, 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- and post-launch experience.
Experience with global regulatory submissions and interactions with major regulatory agencies.
Demonstrated ability to lead, coach, and mentor other 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 meetings for alignment and endorsement.

Responsibilities

Own the overall scientific and clinical safety content and safety strategy for assigned assets or indications.
Ensure high-quality implementation and delivery of the Safety & Strategy Management Team and Safety Surveillance Team for assigned assets.
Set safety team goals aligned with therapeutic-area and product strategy.
Own safety target product profiles, Safety Go/No Go criteria, safety communications and messaging, and toxicity-management guidance.
Represent Global Patient Safety at governance forums, product teams, medical affairs review committees, and advisory-board meetings.
Ensure the quality of risk management plans, periodic safety reports, regulatory submissions, and responses to health authority queries, and ensure compliance with pharmacovigilance regulations.
Lead responses to complex technical safety issues for assigned assets.
Provide safety contributions to study designs and study concept delivery.
Guide safety physicians and scientists on program design, monitoring, data interpretation, communications, and post-marketing surveillance.
Ensure work by self and team complies with Safety, Health and Environment standards and other relevant regulations and standards.
Represent the company in safety-related interactions with health authorities, ethics committees, marketing companies, investigators, and study sites, resolving safety issues and providing clarifications.
Promote cross-functional, proactive, solutions-oriented teamwork and implement new processes, systems, learning, and ways of working.
Prioritize risk-mitigation strategies and effective troubleshooting.
Line-manage, lead, coach, and mentor safety physicians and/or scientists.
Maintain current knowledge of safety scientific literature and emerging clinical safety developments, and communicate impactful information.
Ensure appropriate collection and interpretation of data to determine risks and inform global product labeling.
Deliver balanced, statistically robust analyses of clinical safety data to support interpretation and develop proposals.
Serve as a source of scientific and clinical safety expertise for product teams.
Maintain global networks and collaborate 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.
Support in-licensing opportunities when required.