Global Safety Program Lead

Job Title: Global Safety Program Lead

Introduction to role:
Are you ready to make a significant impact in the field of Oncology? As a Global Safety Program Lead, you will be accountable to the Global Safety Head for the safety strategy, delivery, and oversight of assigned assets. You will collaborate with safety physicians and scientists to develop, and apply safety strategies at both asset and study levels. This role requires critical thinking to optimize benefit-risk and maintain a competitive advantage. You will also line lead a team of safety physicians and scientists and may need to deputize for the Global Safety Head. Operating according to the highest ethical, quality, and compliance standards is critical.

Accountabilities:
Safety Expert:

• 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 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 guidelines for toxicity management of the asset.
• Accountable for project representation for Global Patient Safety at governance and other forums where safety is involved.
• Accountable for the quality of key safety results 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).
• Accountable for safety contribution to study designs and study concept delivery within their assigned program.
• Provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of clinical programs for the assigned asset(s).
• Leads the safety physicians and scientists to support the safety strategy and input into program design, monitoring, data interpretation from pre-clinical and clinical studies, communication, post-marketing surveillance, epidemiology, pre-clinical literature, epidemiology for each asset.
• Ensures compliance with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
• Represents the Company and is 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.
• Encourages collaborative and proactive team actions and behaviors across functions.
• Accountable for implementation of new processes, systems, learning, including new ways of working.
• Prioritizes risk mitigation strategies and effective troubleshooting.
• Line manages a team of safety physicians and scientists

Scientific clinical safety analytical accountabilities:

• Maintains up-to-date knowledge of relevant safety scientific literature and communicates key impactful information clearly.
• Accountable for proper data collection and interpretation to determine risks and inform labels 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 analyzing and interpreting scientific and clinical safety data.

Essential Skills/Experience:

• Medical degree or experience 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 on 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 results, standards, and processes at a global level; including pre and post-launch experience
• Experience with global regulatory submissions and interacting with major regulatory agencies
• Strong ability to successfully lead, coach, and mentor other safety medical directors/scientists
• Available to travel domestically and internationally
• Ability to present sophisticated topics to senior leaders at safety and development governances for alignment and endorsement

Desirable Skills/Experience:

• PhD or equivalent experience (or other scientific field)
• Excellent independent judgment based on groundbreaking knowledge and expertise
• Excellent speaking skills; industry conference speaking experience
• Demonstrated clinical safety and research expertise in an appropriate disease area

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire medicines. In-person working gives 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.

Join AstraZeneca's Oncology R&D team where we push the boundaries of science to change the practice of medicine. Our commitment to following the science drives us to transform patient outcomes through innovative ways. With one of the broadest Oncology pipelines in the industry, you'll have opportunities to work with novel drugs and make a real difference.

Ready to make an impact? Apply now!

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 authorisation and employment eligibility verification requirements.