Safety and Pharmacodynamic Biomarker Associate Director
Safety and Pharmacodynamic Biomarker Associate Director
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 we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're 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
- 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 e.g. “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
- 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
The position is located in South San Francisco, CA
The AstraZeneca South San Francisco campus is situated in the heart of the world’s most prestigious life science and tech cluster, The Cove’s location provides access and visibility.
South San Francisco is a single world-class facility in the Cove at Oyster Point, in the heart of the area’s vibrant biotechnology and technology community. It’s our newest site that’s been designed to enable side-by-side talent to make the impossible, possible at the center of the biotechnology and high-tech industry.
AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It’s our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees’ varying needs, offers valuable choices, and is highly competitive.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
Come and join our journey - Apply today!
Where can I find out more?
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Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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 authorisation and employment eligibility verification requirements.