Medical Director, Patient Safety Physician, Cell Therapy - Immunology

Do you have expertise in, and passion for Patient Safety in Immunology or Autoimmunity? 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 innovativelife changing medicines such as cell and gene therapies (CGT)? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies. Working with one of the broadest cell therapy pipelines in the industry offers the possibility to advance the most novel CGT technologies at all development stages across multiple indications. It takes each of us to challenge our thinking to keep pushing our pipeline forward and shape the future of cell and gene therapies.

As a Medical Director, Senior Patient Safety Physician, Cell Therapy Immunology, you will report to the Cell Therapy ImmunologyGlobal Safety Project Lead (GSPL). You will be a senior leader within the Cell Therapy Patient Safety Unit (CTPSU) and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca cell therapies in immunology and autoimmune diseases. You will also have a role in shaping the culture of the departmentand 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.

Main Role Responsibilities:

• Providing strategic Patient Safety input to CGT drug development programs as part of a global matrix teamwith high-quality contribution to Safety & Strategy Management Team (SSaMT) deliverables

• Responsible for safety contribution to study designs and study concept delivery within their assigned study/program

• Collaboration with PS team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings including safety signal validation.

• Ensuring expert input to safety-relevantelements of study design and interpretation, including efficient use of digital/ artificial intelligence (AI)tools and methodology (e.g.adverse event visualisation and disproportionality analysis.

• Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Review Board.

• Leading the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities for assigned studies/products.

• Leading medico-scientific contributions to risk management plans (RMPs) for assigned products and to Periodic Reports, including PBRERs, DSURs.

• Authoring and accountable for the Safety-related aspects of the Target Product Profile (TPP) and internal Go/No-Go Investment Decisions (ID) for the CTG product throughout its lifecycle

• More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external partners.

• May be required to support in-licensing opportunities.

NecessaryCandidate Requirements:

• MedicalDegree or equivalent.

• 1+ years of proven clinical experience as a physician or academic clinician.

• High level of medical competence, with an ability to balance this with industry standards to achieve business goals

• 1+ years of drug development/patient safety experience.

• Detailed understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience of Patient Safety related to clinical trials and marketed products in any relevant field such as Pharmaceutical Industry, Regulatory Agency, or Public Health agency

• Experience in designing, overseeing, and implementing clinical studies with a focus on patient safety, including adverse event monitoring, safety data review, signal detection and evaluation, and interpretation of trial results to inform benefit–risk assessments and safety labeling.

• Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making.

• Demonstrated ability to influence key business partners within and outside of company

• Proficiency with both written and verbal communications

Additional Preferred Expertise:

• MSc/PhD in scientific discipline

• Basic and translation Research experience in the GCT field

• Medical specialty, or documented training, in immunology and/or autoimmune diseases

• 2+ years of proven clinical experience

• Immunology therapeutic area expertise and commercial understanding

• Documentable strategic leadership expertise is Patient Safety of complex drug programs

• Extensive general medical knowledge

• Able to work across therapeutic areas (TAs) and functions

• Regular user of AI tools to conduct business activities (e.g. Chat-GPT, Claude, various Large Language Models (LLMs), Agentic AI)

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

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

The annual base pay for this position ranges from 241,613.60 USD Annual to $362,420.40. 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. ​

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.