Global Safety Program Lead
Global Safety Program Lead
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Job Description
This is what you will do:
The Global Safety Program Lead is accountable to the Global Safety Head for the safety strategy delivery and oversight of the assigned asset(s); the professional will 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 will be required at times to deputise for the Global Safety Head.
The Global Safety Program Lead will operate according to the highest ethical quality and compliance standards in compliance as provided by 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.
- Accountable for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).
- 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.
- 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
- Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved eg DRC eCRC SARB FSIRB and DSMB/DMC Medical Affairs Review Committees (MARC) product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.
- Accountable for the quality of key safety deliverables e.g. Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs) compliance and adherence to PV regulations of the assigned asset(s).
- Leads response to complex technical issues for specific safety aspects for the assigned asset(s).
- Is accountable for safety contribution to study designs and study concept delivery within their assigned program
- Through integrated understanding of the product strategy provides strategic safety knowledge and support to the safety medical directors and scientists through initiation and completion of the clinical programs for the assigned asset(s).
- Leads the safety physicians and scientists to support the safety strategy and input into the program design monitoring and data interpretation from preclinical and clinical studies communication and postmarketing surveillance epidemiology preclinical and literature epidemiology for each asset.
- Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
- Represents the Company and accountable for the quality of safety delivery e.g. regulatory submissions answers to Health Authority Queries Ethic Committees Marketing Companies investigators/sites and provides clarifications as well as solves safety issues in the study team.
- May be required to support inlicensing opportunities.
- Promotes and enables crossfunctional proactive and solutionsorientated team actions and behaviours
- Accountable for implementation of new processes systems and learning including new ways of working.
- Prioritizes risk mitigation strategies and effective trouble shooting.
- Line manages a team of safety physicians and / or scientists.
Scientific clinical safety analytical accountabilities
- Maintains uptodate knowledge of the relevant safety scientific literature and is able to clearly communicate key impactful information
- Accountable for proper data collection and interpretation for determination of the risks and inform the label in markets globally
- 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 the analyses and interpretation of scientific and clinical safety data.
You will need to have:
- Medical degree or equivalent degree in biomedicine or science
- 5 years 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 crossfunctional leaders on decisionmaking (e.g. Clinical Development Medical Affairs Regulatory Affairs).
- Thorough knowledge and understanding of pharmacovigilance & 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 scientific discipline.
- Excellent independent judgment based on leadingedge knowledge and expertise.
- Excellent speaking skills industry conference speaking experience.
- Excellent independent judgment based on knowledge and expertise.
- Demonstrated clinical safety and research expertise in an appropriate disease area.
Date Posted
29Apr2025Closing Date
29Jun2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single 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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.
Required Experience:
Exec
Employment Type
Full-Time
