Overview
Global Safety Program Lead (Senior Director) – Alexion Pharmaceuticals, Inc.
Position posted: 01-Sept-2025 | Closing date: 30-Oct-2025. This role is responsible for safety strategy, delivery, and oversight of the assigned asset(s) and will work with safety physicians and scientists to develop, implement, and apply safety strategy at asset and study levels. The role may deputise for the Global Safety Head and line-manages a team of safety physicians and/or scientists.
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 the asset(s).
* Responsible for overall safety content for the product or indication(s) aligned to GPT strategy; set safety team goals aligned to TA and product strategy.
* Responsible for safety TPP, Safety Go / No Go criteria, safety communication / messaging, and guidelines for toxicity management of the asset.
* Represent Global Patient Safety for governance and other forums (e.g., DRC, eCRC, SARB, FSIRB, DSMB / DMC, MARC, CPT, GPT, Advisory Board meetings) in partnership with GSH.
* Ensure the quality of key safety deliverables (e.g., Risk Management Plans, Periodic Safety Reports) and compliance with PV regulations.
* Lead responses to complex technical safety issues for the asset(s).
* Contribute safety input to study designs and study concept delivery within the assigned program.
* Provide strategic safety knowledge and support to safety medical directors and scientists through initiation, execution, and completion of clinical programs for the asset(s).
* Lead safety physicians and scientists to support safety strategy, program design, monitoring, data interpretation, post-marketing surveillance, and related areas for each asset.
* Ensure compliance with Safety Health and Environment (SHE) standards and relevant regulations.
* Represent the Company and oversee the quality of safety delivery for regulatory submissions and safety-related inquiries, and resolve safety issues in the study team.
* May support in-licensing opportunities.
* Promote cross-functional, proactive, solutions-oriented actions and behaviors.
* Implement new processes, systems, and learning; prioritize risk mitigation and troubleshooting.
* Line manage a team of safety physicians and/or scientists.
Scientific Clinical Safety Analytical Accountabilities
* Maintain up-to-date knowledge of relevant safety scientific literature and clearly communicate key information.
* Be accountable for proper data collection and interpretation to determine risks and inform the label globally.
* Deliver analyses of clinical safety data in a balanced, robust manner to drive interpretations and develop proposals.
* Serve as a source of scientific and clinical safety knowledge for the Product Team in analyses and interpretation of data.
You will need to have
* Medical degree or equivalent degree in biomedicine or science
* 5 years of extensive relevant clinical, safety, and risk management experience in pharma / biotech / CRO, academia, or Health Authorities
* Proven track record of successful clinical safety delivery with strategic influence on clinical studies / programs
* Ability to collaborate across a matrixed environment and influence cross-functional leaders
* Thorough knowledge of pharmacovigilance and safety deliverables, standards, and processes globally, including pre- and post-launch experience
* Experience with global regulatory submissions and interacting with major regulatory agencies
* Demonstrated ability to lead, coach, and mentor other safety directors / scientists
* Ability to travel domestically and internationally
* Ability to present complex topics to senior leaders at safety and development governances for alignment
We would prefer for you to have
* PhD (or other complementary degree) in a scientific discipline
* Excellent independent judgment based on knowledge and expertise
* Excellent speaking skills and industry conference experience
* Demonstrated clinical safety and research expertise in an appropriate disease area
Company information
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to belonging and do not discriminate based on race, color, religion, creed, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, parental status, military status, protected veteran status, disability, or other protected characteristics. Reasonable accommodations are available. For accommodations, contact Alexion participates in E-Verify.
Seniority level
* Director
Employment type
* Full-time
Job function
* Consulting, Information Technology, and Sales
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