Global Safety Strategy Lead

AstraZeneca GmbH; Boston, Northern (MA, KY); Hybrid; USD 281,000 - 421,000; Full time

Job summary

AstraZeneca GmbH is seeking a Global Safety Program Lead, Senior Director to oversee safety strategy, delivery, and oversight of assigned assets. You will manage safety physicians/scientists, deputise for the Global Safety Head as needed, and ensure compliance with global PV regulations and GxP standards.

You will drive safety content, governance representations, and high-quality deliverables (RMPs, PSRs) while collaborating across functions and traveling as required to support global programs.

Qualifications

• Medical degree or equivalent degree in biomedicine or science.
• 5 years extensive relevant clinical, safety and risk management experience in pharma/biotech/CRO/academic/health authorities.
• Proven track record of successful clinical safety delivery with strategic influence to studies/programs.
• Ability to collaborate across a matrixed environment and influence cross-functional leaders (clinical development, medical affairs, regulatory).
• Thorough knowledge of pharmacovigilance & safety deliverables, standards and global processes, incl. pre/post-launch.
• Experience in global regulatory submissions and interacting with major regulatory agencies.
• Demonstrated ability to lead, coach, and mentor safety directors/scientists.
• Willingness to travel domestically and internationally.
• Ability to present complex topics to senior safety and development governance for alignment.

Responsibilities

• Accountable for overall safety content for the assigned asset(s).
• Implement and ensure high-quality delivery of Safety Strategy Management Team and Safety Surveillance Team.
• Set safety goals aligned to asset strategy and product strategy.
• Own safety TPP, Go/No Go criteria, and toxicity guidelines for assets.
• Represent safety in governance forums (DRC, eCRC, SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT).
• Ensure quality of safety deliverables (RMPs, PSRs) and PV regulatory compliance.
• Lead complex safety issues for the asset(s).
• Contribute safety input to study designs and delivery within the program.
• Provide strategic safety knowledge to safety medical directors/scientists throughout clinical programs.
• Lead safety teams to support strategy, design, monitoring, and data interpretation from preclinical to post-marketing.

Skills

Clinical safety

Regulatory knowledge

Cross-functional leadership

Data analysis

Travel readiness

Stakeholder management

Education

Medical degree or equivalent in biomedicine/science

PhD (preferred)

Job description

AstraZeneca GmbH is seeking a Global Safety Program Lead, Senior Director to oversee safety strategy, delivery, and oversight of assigned assets. You will manage safety physicians/scientists, deputise for the Global Safety Head as needed, and ensure compliance with global PV regulations and GxP standards.

You will drive safety content, governance representations, and high-quality deliverables (RMPs, PSRs) while collaborating across functions and traveling as required to support global programs.