Director, Advanced Cell Model External Engagement, Safety Sciences

At AstraZeneca we push the boundaries of science to deliver life-changing medicines. Our global Safety Sciencesorganizationdelivers innovative non-clinical safety science and toxicologyexpertiseto enable the discoverydevelopmentand registration of novel medicinesacross drug modalities and therapeutic areas.

As a science-driven business we continuously strive to innovate to enhance our scientific capabilitiesandaccelerate 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 andalign on anAdvanced Cell Model(ACM)strategic plan aligned withglobal regulatoryroadmaps/guidanceand policyon NAMs andAZ 3Rs.
• Workwith internal stakeholders and external consortia and health authorities to qualifyvalidateand gain acceptance of NAMsin accordance with for exampleregulatory roadmaps/guidance and policy on NAMs.
• Lead influencethrough relevant externalstakeholders and consortiaontheacceptance ofNAMsdatain regulatory submissions.
• ForACMsubmissions contribute to and align AZ methods withstandardizationroadmapsultimately submittingand securing acceptance of relevant ISO applications.The individual will lead efforts to promoterigorin ACMs and devise frameworks forprioritizingACM standards and qualification both internally and for health authority acceptance.
• Impact onAZR&D globally byadvisingothersincluding senior managementondevelopments and updates in regulatory guidance and policy for NAMs globally.
• Responsible forstrengtheningAstraZenecas external reputation and leadership in ACM and NAMs through active participation with industry and health authority consortia.
• ImpactonR&D globallyby leadingcross-enterprisepartnerships with innovation leaders tofacilitatethe sharing of ideas tooptimizetheapplication ofACMaligned to the3Rs providing expert technical direction and problem solving.