{"id":3738689,"url":"https://alion.io/job/astrazeneca-global-safety-program-lead-2","title":"Global Safety Program Lead","company":{"id":13195,"name":"AstraZeneca","domain":"astrazeneca.com","url":"https://alion.io/company/astra-zeneca","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":93,"open_postings":165,"ghost_share":0.006,"stale_share":0.388,"repost_share":0.103,"time_to_fill_p50_days":19,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Gaithersburg, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":288059,"max":432088,"currency":"USD","period":"year","gross":null,"usd_annual":432088},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-11-04T10:54:37Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-05T21:57:24Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"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.\nThe 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.\nAccountibilities:\nSafety Expert\nAccountable for the overall scientific and clinical safety content for the assigned asset(s) or indications. \nAccountable for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s). \nResponsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy. \nFor 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 \nIs 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. \nAccountable 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). \nLeads response to complex technical issues for specific safety aspects for the assigned asset(s). \nIs accountable for safety contribution to study designs and study concept delivery within their assigned program \nThrough 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). \nLeads 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. \nEnsures 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. \nRepresents 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. \nMay be required to support in-licensing opportunities. \nPromotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours \nAccountable for implementation of new processes, systems and learning, including new ways of working. \nPrioritizes risk mitigation strategies and effective trouble shooting. \nLine manages a team of safety physicians and / or scientists. \nScientific clinical safety analytical accountabilities\nMaintains up-to-date knowledge of the relevant safety scientific literature, and is able to clearly communicate key impactful information, \nAccountable for proper data collection and interpretation for determination of the risks and inform the label in markets globally \nDelivers analyses of clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals. \nServes as a source of scientific and clinical safety knowledge for the Product Team, in the analyses and interpretation of scientific and clinical safety data. \nMessaging and External Impact\nMaintains a high degree of understanding and awareness of new and emerging clinical safety developments, globally. \nMaintains strong networks globally and works with international colleagues and with external alliance partners on safety initiatives and regulatory issues. \nIf required, able to provide safety guidance for investigator-initiated trials in cooperation with regional marketing companies. \nThis Job description is not exhaustive and may include other other job-related duties as assigned.\nEssential for the role\nMedical degree or equivalent degree in biomedicine or science \n5 years extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities \nProven track record of successful clinical safety delivery with demonstrated examples of strategic influence to clinical studies/programs. \nAbility to collaborate across a matrixed environment and influence cross-functional- leaders on decision-making (e.g. Clinical Development, Medical Affairs, Regulatory Affairs). \nThorough knowledge and understanding of pharmacovigilance & safety deliverables, standards and processes at a global level; including pre and post launch experience. \nExperience of global regulatory submissions and interacting with major regulatory agencies. \nDemonstrated ability to successfully lead, coach, and mentor other safety medical directors/scientists. \nAvailable to travel domestically and internationally \nDemonstrated ability to present complex topics to senior leaders at safety and development governances for alignment and endorsement. \nDesirable for the role\nPhD (or other complementary degree) in scientific discipline. \nExcellent, independent judgment based on leading-edge knowledge and expertise. \nExcellent speaking skills, industry conference speaking experience. \nExcellent, independent judgment based on knowledge and expertise. \nDemonstrated clinical safety and research expertise in an appropriate disease area.\nThe annual base pay (or hourly rate of compensation) for this position ranges from $288,059.20 - $432,088.80USD. 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), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. 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.\nDate Posted\n04-Nov-2026Closing Date\n30-Dec-2026Our 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. 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