Overview
This is what you will do: The Global Safety Program Lead, Senior Director is accountable to the General Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s); work with safety physicians and scientists responsible for the development, implementation, and application of safety strategy at asset and study level. Acts strategically to generate opportunity and value for the asset or indication to optimize benefit risk and maintain a competitive advantage. Line manages a team of safety physicians and/or scientists. They may deputise for the Global Safety Head when required. The Global Safety Program Lead, Senior Director will operate according to the highest ethical, quality and compliance standards in compliance with global and local regulations, GxP practice and AZ procedures.
You will be responsible for:
- Safety Expert: Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications.
- Safety Expert: Accountable for the implementation and high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).
- Safety Expert: Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy.
- Safety Expert: For the assigned asset(s), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset.
- Safety Expert: Represents Global Patient Safety at governance and other forums where safety is involved (e.g., DRC, eCRC, SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT, and Advisory Board meetings) in partnership with GSH.
- Safety Expert: Accountable for the quality of key safety deliverables (e.g., Risk Management Plans and Periodic Safety Reports), compliance and adherence to PV regulations of the assigned asset(s).
- Safety Expert: Leads response to complex technical issues for specific safety aspects for the assigned asset(s).
- Safety Expert: Accountable for safety contribution to study designs and study concept delivery within their assigned program.
- Safety Expert: Provides strategic safety knowledge and support to safety medical directors and scientists through initiation, execution, and completion of clinical programs for the assigned asset(s).
- Safety Expert: Leads safety physicians and scientists to support the safety strategy and input into program design, monitoring, and data interpretation from pre-clinical and clinical studies, post-marketing surveillance, epidemiology, and literature for each asset.
- Safety Expert: Ensures that work complies with Safety, Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
- Safety Expert: Represents the Company and accountable for the quality of safety delivery (e.g., regulatory submissions, responses to Health Authority queries, Ethics Committees, Marketing Companies, investigators/sites) and provides clarifications and resolves safety issues in the study team.
- Safety Expert: May be required to support in-licensing opportunities.
- Safety Expert: Promotes and enables cross-functional, proactive, and solutions-oriented team actions and behaviors.
- Safety Expert: Accountable for the implementation of new processes, systems, and learning, including new ways of working.
- Safety Expert: Prioritizes risk mitigation strategies and effective troubleshooting.
- Line manages a team of safety physicians and/or scientists.
Scientific clinical safety analytical accountabilities
- Maintains up-to-date knowledge of relevant safety scientific literature and clearly communicates key impactful information.
- Accountable for proper data collection and interpretation to determine risks and inform the label in global markets.
- Delivers analyses of clinical safety data in a balanced and statistically robust manner to drive interpretations and develop novel proposals.
- Serves 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 the pharmaceutical, biotech, CRO industry, academia or Health Authorities.
- Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence to clinical studies/programs.
- Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making (e.g., Clinical Development, Medical Affairs, Regulatory Affairs).
- Thorough knowledge and understanding of pharmacovigilance and safety deliverables, standards and processes at a global level, including pre- and post-launch experience.
- Experience of global regulatory submissions and interacting with major regulatory agencies.
- Demonstrated ability to successfully lead, coach, and mentor other safety medical directors/scientists.
- Available to travel domestically and internationally.
- Demonstrated ability to present complex topics to senior leaders at safety and development governances for alignment and endorsement.
We would prefer for you to have:
- PhD (or other complementary degree) in a scientific discipline.
- Excellent, independent judgment based on leading-edge knowledge and expertise.
- Excellent speaking skills and industry conference speaking experience.
- Demonstrated clinical safety and research expertise in an appropriate disease area.
Date Posted
13-Oct-2025
Closing Date
29-Nov-2025
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.
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