Global Safety Program Lead

This is what you will do :

The individual is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s); the role holder 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 deputize for the Global Safety Head. The individual 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 :

• 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, execution, 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 pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical 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 in-licensing opportunities.
• Promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviors
• 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.

You will need to have :

We would prefer for you to have :

Expectation of working in the office 3 days a week : When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification

Date Posted

11-Feb-2025

Closing Date

28-Feb-2025Alexion 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 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.