Director, Advanced Cell Model External Engagement, Safety Sciences

At AstraZeneca, we push the boundaries of science to deliver life-changing medicines. Our global Safety Sciences organization delivers innovative non-clinical safety science and toxicology expertise to enable the discovery, development and registration of novel medicines across drug modalities and therapeutic areas.  

As a science-driven business, we continuously strive to innovate to enhance our scientific capabilities and accelerate the speed at which we bring medicines forward.  

Advanced Cell Models (ACM), such as organoids and Microphysiological Systems (MPS), are New Approach Methods (NAMs) used for safety assessment and to study disease biology. We are playing a leading role in the field to apply ACM to drug discovery and development, in particular to predict and optimize therapeutic index for novel candidate drugs.

To enhance our ACM strategy, we are looking to recruit a Director, Advanced Cell Model External Engagement, Safety Sciences. The role will be based at our R&D site in Gaithersburg, MD. It is part of the Advanced Cell Models Team and reports to the Senior Director, Head of Advanced Cell Models, Safety Sciences.

• Develop and align on an Advanced Cell Model (ACM) strategic plan aligned with global regulatory roadmaps/guidance and policy on NAMs and AZ 3Rs.  
• Work with internal stakeholders and external consortia and health authorities to qualify, validate and gain acceptance of NAMs in accordance with, for example, regulatory roadmaps/guidance and policy on NAMs.  
• Lead influence through relevant external stakeholders and consortia on the acceptance of NAMs data in regulatory submissions.  
• For ACM submissions contribute to and align AZ methods with standardization roadmaps ultimately submitting and securing acceptance of relevant ISO applications. The individual will lead efforts to promote rigor in ACMs and devise frameworks for prioritizing ACM standards and qualification both internally and for health authority acceptance. 
• Impact on AZ R&D globally by advising others, including senior management, on developments and updates in regulatory guidance and policy for NAMs globally. 
• Responsible for strengthening AstraZeneca’s external reputation and leadership in ACM and NAMs through active participation with industry and health authority consortia.  
• Impact on R&D globally by leading cross-enterprise partnerships with innovation leaders to facilitate the sharing of ideas to optimize the application of ACM aligned to the 3Rs, providing expert technical direction and problem solving.  

Minimu