Associate Director, Patient Safety Scientist, Cell Therapy - Immunology

AstraZeneca • Gaithersburg, MD

68d

About The Position

In this role, you will collaborate with Patient Safety Physicians, other Patient Safety Scientists, and colleagues from across AstraZeneca, including Clinical Project Teams, to review, analyze, and interpret safety data from clinical trials and marketed products. You will author and contribute to safety documents and regulatory reports, present safety analyses at meetings, and evaluate data from multiple sources to define cell therapy safety profiles and manage patient risks. Depending on your experience and seniority, you may also lead meetings, deliver complex analyses, and take on broader strategic responsibilities. At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing. This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs, spanning the entire life cycle of cell therapy development and peri-/post-submission. Our Scientists and Physicians play a strategic role in developing our medicines and the safety science of the program. AstraZeneca’s oncology Cell and Gene Therapy (CGT) pipeline, which includes novel technologies and combinations, provides an intellectual challenge to the safety teams, requiring a broad portfolio and scientific management approach to projects. Our teams’ experience develops as our portfolio does. We are looking for an experienced Associate Director, Patient Safety (PS) Scientist to join our Patient Safety department, working in the Cell Therapy Immunology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Program Lead (GSPL), Safety Physician and other Patient Safety Scientists. You will contribute to training and coaching junior colleagues. You will contribute to high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s). You will play a leading role in delivering the clinical safety strategy for your assigned cell therapy study/project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca and externally, including colleagues within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams. As an Associate Director, Patient Safety Scientist, you will report to the Cell Therapy Immunology Global Safety Project Lead (GSPL). You will provide leadership in aggregating, reviewing, analyzing and interpreting safety-related data to generate information to support safety decision-making by study/project teams, as well as patients, prescribers and payers, with the goal of protecting patients. You will apply your strong PV, immunology, cell therapy, scientific experience, knowledge and skills to lead in all aspects of safety documentation, including safety surveillance, signal evaluation, periodic report writing, authoring and/or providing strategic safety input to regulatory documents, e.g. regulatory reports and health authority responses, and the safety content of marketing authorization applications. Patient Safety sits within the Chief Medical Office, where we have a crucial role to play. This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our medicines portfolio means we have a CGT drug-development pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines for oncology patients. Faced with complex disease challenges, we focus on exceptional performance to drive the best and most transformative CGT oncology development programs ever.

Requirements

• A bachelor’s degree in sciences/pharmacy/nursing, or related field, with relevant experience or an advanced degree with relevant experience
• Patient Safety and/or Drug Development experience working in or leading safety and/or scientific activities in at least 3 of the following areas:
• Clinical drug development in early and/or late phase: develop program level safety strategy, including proactive risk identification and mitigation planning
• MAA/BLA submissions setting strategy; preparation and authoring of the safety related aspects of the Common Technical Document
• Periodic Safety Reports to establish and lead strategy, preparation and authoring
• Risk Management Plans to establish and lead strategy, preparation and authoring
• Governance board interactions and communication across a range of activities
• Good knowledge of PV regulations in the US, EU, and UK, as well as ICH guidelines
• Demonstrated ability to handle more than one project simultaneously, prioritizing well and recognizing key issues
• Ability to work effectively in an advanced matrix structure
• Fluent in written and verbal English

Nice To Haves

• MSc/PhD/PharmD in immunology and/or autoimmune diseases
• CGT product development and CGT safety monitoring experience
• Good understanding of pharmacoepidemiology
• Expertise in using AI tools (e.g. Chat-GPT, Claude, various Large Language Models (LLMs), Agentic AI)
• Good knowledge of PV regulations in China, Australia, Japan, rest of Asia

Responsibilities

• Leads and/or conducts proactive pharmacovigilance and risk management planning for cell therapies, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSPL and others as appropriate.
• Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
• Leads the collaboration with GSPL and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
• Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
• Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees