Associate Director, Cell Therapy Senior Patient Safety Scientist – Oncology Full-time

Associate Director, Senior Patient Safety (PS) Scientist

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, Senior Patient Safety (PS) Scientist to join our Patient Safety department, working in the Cell Therapy Oncology/Haemato-oncology 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, Senior Patient Safety Scientist, you will report to the Cell Therapy Oncology 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, oncology, 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.

Essential Requirements

• A bachelor's degree in sciences/pharmacy/nursing, or related field, with relevant experience or an advanced degree with relevant experience
• At least 5 years' experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry
• 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
• Post-Marketing Surveillance, including signal detection and evaluation
• 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

Preferred Requirements

• MSc/PhD/PharmD in scientific discipline
• CGT product development and CGT safety monitoring experience
• Advanced 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

Location: Gaithersburg, MD, USA

The annual base pay for this position ranges from $126,991.20 USD Annual to $190,486.80. 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.

So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.