Director- Patient Safety

Job Title: Director Patient Safety

GCL: F

At AstraZeneca, we are committed to delivering innovative medicines that address significant unmet medical needs. Our Oncology-Hematology pipeline includes novel combinations, biologics, cell therapies, and other innovative modalities that are transforming the treatment landscape.

This is an exciting opportunity to join the Patient Safety function within the Hematology Oncology Therapeutic Area. As a Director, Safety Physician, you will provide strategic medical and scientific leadership across the development and lifecycle management of assigned assets. You will help define the safety strategy, evaluate emerging safety information, and support robust benefit–risk decision-making to protect patients and enable the safe and effective use of AstraZeneca medicines.

Working across a global, highly collaborative matrix, you will partner with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Commercial, Clinical Operations, and other functions. You will represent Patient Safety in key governance forums and contribute to regulatory interactions and development milestones.

What you will do

You will be accountable for the implementation of clinical and scientific safety strategy for assigned assets, indications, or projects across the product lifecycle, from early clinical development through regulatory submission and, where applicable, the post-marketing setting.

• Leading risk management evaluation and resolution for assigned products and projects. Accountability/responsible for the following: 
• Responsible for the overall scientific and clinical safety content for the assigned asset(s) or indications.  
• Responsible for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).  
• Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy.  
• For the assigned asset(s), responsible for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset  
• Responsible for safety contribution to study designs and study concept delivery within their assigned program  
• Chairing and/or directing the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda from inception to closure 
• Representing AZ GPS at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetings 
• Detecting, validating, and managing pre-and/or post-approval safety signals through to resolution 
• Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required 
• Identifying, initiating, and managing to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary 
• Overseeing safety sections of documents and safety interactions with Regulatory authorities. This may include: authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs 
• Delivers analyses of clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals.  
• Serves as a source of scientific and clinical safety knowledge for the Product Team, in the analyses and interpretation of scientific and clinical safety data.  
• This job description is not exhaustive and may include other job-related duties as assigned. 

The team and therapeutic area

Patient Safety is a strategic function within the Chief Medical Office. Our teams play a central role in identifying and managing risks throughout the lifecycle of AstraZeneca medicines.

Hematology Oncology is a scientifically dynamic area with rapidly evolving standards of care and innovative treatment approaches. The portfolio includes therapies for diseases such as lymphoma, leukemia, and other hematologic malignancies, often involving complex treatment combinations and novel mechanisms of action.

Success in this role will require a broad scientific perspective, strong clinical judgment, strategic thinking, and the ability to lead through influence in a global matrix environment.

Essential requirements

• Medical degree such as MD, or equivalent. A PharmD, PhD, MSc, or other advanced scientific degree may be considered when combined with substantial relevant Patient Safety and drug-development experience.
• Significant experience in Patient Safety, Pharmacovigilance, Clinical Development, or a related medical or scientific discipline within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated experience providing medical or scientific safety leadership across clinical development programmes and/or marketed products.
• Strong knowledge of clinical safety evaluation, signal management, aggregate data review, risk management, and benefit–risk assessment.
• Experience contributing to several of the following areas:
  • Early- and/or late-phase clinical development
  • Safety strategy and proactive risk-management planning
  • Investigator’s Brochures and DSURs
  • PBRERs/PSURs and periodic safety reporting
  • Risk Management Plans
  • Regulatory submissions and health-authority responses
  • Signal detection, evaluation, and management
  • Governance or safety committee interactions
  • Safety communication and product information updates
• Good knowledge of applicable global pharmacovigilance and clinical development regulations, including relevant US, EU, and international requirements.
• Demonstrated ability to interpret complex clinical safety data and communicate conclusions clearly, accurately, and objectively.
• Experience working effectively in a global matrix organisation and influencing cross-functional teams without direct authority.
• Ability to manage multiple complex priorities, make sound decisions under uncertainty, and deliver high-quality work to tight timelines.
• Excellent written and verbal communication skills in English.

Desirable requirements

• Strong knowledge or experience in hematology and/or oncology, particularly lymphoma, leukemia, or other hematologic malignancies.

When we put unexpected teams in the same room, we fuel 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, at least 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 bold world.

Why AstraZeneca?

AstraZeneca offers the opportunity to work at the forefront of biomedical innovation, alongside colleagues who are committed to transforming patient outcomes. In this role, you will contribute directly to the safety strategy of important hematology oncology medicines and help ensure that decisions are guided by rigorous science, sound medical judgment, and a clear focus on patients.

This is an opportunity to make a meaningful impact across the full product lifecycle while developing your leadership, therapeutic-area expertise, and influence within a global Patient Safety organisation.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.