Global Safety Program Lead

AstraZeneca • Mississauga, ON

6d • Hybrid

About The Position

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and Blue Sky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected, which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Join us at AstraZeneca in the Vaccines and Immune Therapies therapeutic area as a Global Safety Program Lead. This role is pivotal in our mission to provide long-lasting immunity to millions of people and directly impact the lives of populations around the world. We are at an exciting frontier of medicine, and we need your expertise to help us turn our ambition into a reality. Overview 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 deputise 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.

Requirements

• 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 & 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.

Nice To Haves

• PhD (or other complementary degree) in scientific discipline.
• Excellent, independent judgment based on groundbreaking 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.

Responsibilities

• 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, 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 to follow 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 provide 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 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.
• Maintains up-to-date 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.
• Maintains a high degree of understanding and awareness of new and emerging clinical safety developments, globally.
• Maintains strong networks globally and works with international colleagues and with external alliance partners on safety initiatives and regulatory issues.
• If required, able to provide safety guidance for investigator-initiated trials in collaboration with regional marketing companies.

Benefits

• We balance the expectation of being in the office while respecting individual flexibility.
• Commitment to lifelong learning, growth and development for all.
• An inclusive culture where you will connect different thinking to generate new and valuable opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior