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 or clinical development 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. 

• Strong experience and knowledge of Gene & Cell therapy

• 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 documented training, in oncology and/or haemato-oncology. 

• Basic and/or Translational Research background, including authoring peer reviewed publications. 

• Good knowledge of PV regulations in China, Australia, Japan, rest of Asia. 

• Recognized subject‑matter expertise and sound independent judgment in clinical safety; disease area safety leadership experience. 

• Experience speaking at industry conferences and shaping external safety messaging. 

• Experience supporting in‑licensing/due diligence from a safety perspective. 

• Proven ability to embed new processes/systems and drive continuous improvement in safety ways of working. 

The 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. 

Date Posted

Closing Date

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.