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Safety and Pharmacodynamic Biomarker Associate Director

Posted on Apr 5, 2021 by AstraZeneca

San Francisco, CA 94101
Immediate Start
Annual Salary

Are you seeking an advanced opportunity to lead safety biomarker discovery? Are you looking for an engaged and vibrant work environment?

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But were more than one of the worlds leading pharmaceutical companies. At AstraZeneca, were proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The Integrated Bioanalysis (iBA) group within the Clinical Pharmacology and Quantitative Pharmacology department at AstraZeneca seeks an accomplished biologist to lead safety biomarker discovery and contribute to pharmacodynamic biomarker development efforts at the Associate Director level. The ideal candidate will have a track record of initiating biomarker discovery efforts using a variety of platform technologies (qPCR, ddPCR, NGS, NanoString or flow cytometry, etc.), experience in utilizing complex in-vitro/ex-vivo model systems to gain mechanistic insights into therapeutic molecules, contributing to pre-clinical/clinical programs and leading a group of laboratory-based scientists. Scientific expertise in one or more of the following areas is preferred: pulmonary-, hepatic- or renal-cell biology, inflammatory disease or cancer.

Major Duties and Responsibilities

Build and implement safety biomarker discovery strategies for multiple drug modalities across several therapeutic areas (oncology, neuroscience, cardiovascular, renal and metabolic)
Contribute to ongoing pharmacodynamic biomarker discovery and development efforts for multiple drug modalities across several therapeutic areas
Provide strategic leadership in the development, qualification and implementation of biomarker assays for therapeutic products at pre-clinical or clinical stages
Lead 2-4 PhD-level bioanalytical scientists in laboratory-based biomarker identification and assay development efforts, develop junior scientists into future scientific leaders within the iBA organization
Monitor engagement efforts with Commercial Research Organizations (CRO) in assay transfer, validation and implementation of bioanalytical & biomarker assays
Represent the iBA organization on therapeutic teams, contribute to regulatory interactions (IND, NDA/BLA submissions) and serve as the iBA SME in safety biomarkers
Enhance iBA reputation for scientific excellence by presenting at internal and external meetings and contributing to- or leading publication of pre-clinical or clinical biomarker assay results
Contribute to iBA SSF site leadership team
Educational Requirements and Qualifications

PhD in relevant field (cell/molecular biology, biochemistry, immunology) and post-doctoral training in related area
10 years of experience (minimum) in the translational biomarker area in the biopharmaceutical sector
Essential Skills

Demonstrable management/leadership experience in the biopharmaceutical sector
Extensive experience in biomarker discovery and assay development to monitor safety or pharmacodynamic activities of therapeutic products
Broad, working knowledge of multiple platform technologies to assess pharmacodynamic activities such as qPCR, ddPCR, NGS, NanoString, flow cytometry or imaging platforms
Experience in use of in-vitro/ex-vivo model systems eg organ on a chip or air-liquid interface systems
Experience in utilizing multivariate analytical platforms to interpret complex datasets
Knowledge of Good Laboratory/Clinical Practice (GLP or GCP) regulations is preferred
Experience with regulatory authority interactions such as contributing to IND or NDA/BLA submissions is a plus
Special Skills/abilities

Ability to critically assess pre-clinical or clinical therapeutic product development activities
Ability to rapidly understand complex biological pathways targeted by AstraZeneca therapies and leverage understandings to contribute to development success
Ability to manage multiple complex programs and delivery timelines concurrently
Ability to work in a highly-matrixed organization to deliver on goals
Ability to develop scientific staff to succeed in a matrixed structure
Excellent verbal and written communication skills

Reference: 1152694553

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