Associate Director, Bioanalysis (CPSS Cell Therapy)

Associate Director, Bioanalysis (CPSS Cell Therapy) 

Introduction to role 

Are you ready to make a significant impact in the field of cell therapy? Join our dynamic team at AstraZeneca as an Associate Director within Clinical Pharmacology and Safety Sciences (CPSS) Cell Therapy team, where you will lead the design and implementation of robust bioanalytical strategies to support clinical assay endpoints. Your expertise will be crucial in advancing our cell therapy pipeline and transforming the lives of patients. This position is based in either Santa Monica, CA or Gaithersburg, MD.

Accountabilities 

• Lead design and implementation of robust bioanalytical strategies to support clinical assay endpoints, including but not limited to PK/CK/PD, immunogenicity and biomarkers related to cell therapy products to support the AstraZeneca cell therapy pipeline, with special focus on autoimmune and rare diseases. 

• Identify, evaluate scientific and operational capabilities and establish partnerships with selected specialty laboratories and CROs for generation and analysis of bioanalytical data. 

• Lead and oversee assay development, qualification/validation and tech transfer (when appropriate) of cell therapy-related bioassays at CROs or using internal capabilities. 

• Interpret and integrate complex datasets within programs and across the cell therapy immunology and rare disease portfolio. Provide written and verbal updates to key stakeholders. 

• Contribute to publication strategy, prepare data for publication or presentations in internal/external scientific conferences. 

Essential Skills/Experience 

• PhD degree in immunology, cell biology or a related field with 7+ years of relevant industry experience with strong background in cell therapy and demonstrated knowledge autoimmune diseases.  

• Demonstrated experience managing/directing analysis of clinical biospecimens to support clinical trials. 

• Proven experience in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments 

• Able to evaluate and interpret complex data sets using analysis and visualization software (i.e. Cytobank/OMIQ/FCS Express, Tableau/Spotfire/JMP). 

• Work cross-functionally and collaboratively with project stakeholders. 

• Deep understanding of cell therapy biology and up to date with latest analytical methods applicable to characterization of cell therapy products and mechanism of action. 

• Understanding of global regulatory expectations and fitforpurpose analytical requirements, with a record of supporting compliant data packages for IND/CTA/BLA filings. 

• Experience managing assay development teams, overseeing tech transfers, scientific quality and study conduct internally and at CROs. 

• Ability to interpret complex datasets and exceptional ability to communicate results verbally, in writing and in presentations adapting to different audiences as required.