Global Safety Program Lead/Sr Medical Director

The Global Safety Program Lead, Senior Director 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, acting strategically to generate opportunity and value for the asset or indication to optimize benefit‑risk and maintain a competitive advantage. The role also includes line management of a team of safety physicians and/or scientists and may deputise for the Global Safety Head. The Global Safety Program Lead, Senior Director will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice, and AZ procedures. 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, setting safety team goals aligned to TA and product strategy. Accountable for safety TPP, Safety Go/NoGo 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 (eg DRC, eCRC, SARB, FSIRB, DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such as CPT and GPT, and Advisory Board meetings in partnership with GSH). Accountable for the quality of key safety deliverables such as 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 of 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 safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s). 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, communication and post‑marketing surveillance, epidemiology, and literature 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 ensures the quality of safety delivery (e.g., regulatory submissions, answers to Health Authority Queries, Ethics 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‑oriented team actions and behaviours. Accountable for implementation of new processes, systems and learning, including new ways of working. 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 the relevant safety scientific literature and is able to clearly communicate key impactful information. Accountable for proper data collection and interpretation for determination of risks and to 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. Qualifications Medical degree or equivalent degree in biomedicine or science. At least 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 in 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 with global regulatory submissions and interacting with major regulatory agencies. Demonstrated ability to 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. Preferred Qualifications PhD or other complementary degree in a scientific discipline. Excellent, independent judgment based on leading‑edge knowledge and expertise. Excellent speaking skills with industry conference speaking experience. Excellent, independent judgment based on knowledge and expertise. Demonstrated clinical safety and research expertise in an appropriate disease area. Compensation and Benefits The annual base pay (or hourly rate of compensation) for this position ranges from $280,895 to $421,342. Hourly and salaried non‑exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job‐related knowledge, skills, and experience. In addition, our positions offer a short‑term incentive bonus opportunity; eligibility to participate in our equity‑based long‑term incentive program (salaried roles); a retirement contribution (hourly roles); and commission payment eligibility (sales roles). Qualified retirement program [401(k) plan]. Paid vacation and holidays. Paid leaves. Health benefits including medical, prescription drug, dental, and vision coverage. If hired, employee will be in an at‑will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Equal Employment Opportunity Statement Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca