Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology

Opportunity:  Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology Location:   Gaithersburg, US (on-site) 3 days working from the office and 2 days working from home.   Do you have   expertise   in, and passion for Patient Safety in Oncology   and Onco-Hematology ? Would you like to apply your   expertise   to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into innovative life changing medicines? Then AstraZeneca might be the one for you!   AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. Within Global Patient Safety, you will shape the safety strategy of high-impact assets and lead cross-functional teams to   optimize   benefit–risk and   maintain   competitive advantage across development and   post ‑ marketing .   Working with one of the broadest cell therapy pipelines in the industry offers the possibility to advance the most novel Cell and Gene Therapy (CGT) technologies at all development stages across multiple indications.   When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing 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.   As a  Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology , you will report to the   Global Safety Head (GSH) of the Cell therapy Patient Safety Unit (CTPSU) . You will be a senior leader within the CTPSU and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca cell therapies in oncology ,   specifically, but not limited to, the AZD0120 DURGA program in Multiple Myeloma. You will also have a role in shaping the culture of the department and will act as a coach and mentor to more junior Patient Safety staff. You will ensure processes adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements as well as AZ processes.   Accountabilities    In this role, you are accountable to the Global Safety Head , Cell Therapy,   for the   end ‑ to ‑ end   safety strategy, delivery, and oversight of   AZD0120 Multiple Myeloma   program , and potentially other   assets ,   across   pre ‑ clinical , clinical, and   post ‑ marketing . You will:   Lead the Safety Strategy & Management Team ( SSaMT ) and Safety Surveillance Team for assigned asset(s), setting safety goals aligned to therapeutic area and product strategy, and ensuring   high ‑ quality , compliant delivery of safety activities.   Own the scientific and clinical safety content for the asset(s), including safety TPP, safety Go/ No ‑ Go   criteria, toxicity management guidelines, and safety messaging, integrating inputs from clinical, epidemiology,   pre ‑ clinical , and literature.   Represent Global Patient Safety at key governance and external forums (e.g., DRC,   eCRC , SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT, Advisory Boards) in partnership with the Global Safety Head; lead responses to complex technical safety issues.   Ensure the quality, compliance, and   timely   delivery of safety documents (e.g., RMPs, PSURs/PSRs) and safety contributions to study design, protocol concepts, regulatory submissions, HA/EC queries, and labeling for global markets.   Provide strategic safety leadership to safety medical directors and scientists, guiding study and program execution, data monitoring and interpretation, signal management, and   post ‑ marketing   surveillance to inform labeling and risk minimization.   Build and   maintain   strong internal and external networks, including alliance partners, to drive proactive,   cross ‑ functional ,   solution ‑ oriented   safety actions; may support due diligence and   in ‑ licensing   assessments.   Ensuring expert input to safety-relevant elements of study design and interpretation, including efficient use of digital/ artificial intelligence (AI) tools and   methodology   ( e.g.   adverse event   visualisation   and disproportionality analysis).   Line   manage   and   develop   a team of safety physicians and/or scientists;   embed   new processes, systems, and ways of working; prioritize risk mitigation and effective issue resolution;   operate   to the highest ethical, quality,   GxP , and AZ standards.   Essential for the role   Medical degree or equivalent degree in biomedicine or science, with extensive clinical safety/pharmacovigilance experience.   Strong relevant experience in clinical safety and risk management across pharma/biotech/CRO/academia/Health Authorities, spanning pre ‑   and   post ‑ launch .   Proven   track record   of leading asset safety strategy and delivery, with   demonstrated   strategic influence on clinical studies/programs and benefit–risk decisions.   Deep knowledge of global PV regulations, standards, and safety deliverables (e.g., RMPs, PSURs/PSRs), and experience contributing to global regulatory submissions and interactions with major agencies.   Strong matrix leadership and influencing skills with   cross ‑ functional   leaders (e.g., Clinical Development, Medical Affairs, Regulatory Affairs), including representation at senior governance.   Demonstrated   people   leadership: ability to lead, coach, and mentor safety physicians/scientists; excellent communication skills with the ability to present complex topics to senior leaders.   Ability to travel domestically and internationally, as business needs require.   Desirable for the role   PhD or other advanced   degree   in a relevant scientific discipline.   Research experience in the GCT field .   Medical specialty, or