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Sr. Scientist Clinical Immunogenicity

Ort Gaithersburg, Maryland, USA South San Francisco, Kalifornien, USA Anzeigen-ID R-145910 Veröffentlichungsdatum 02/11/2022

Sr. Scientist Clinical Immunogenicity Scientist Job Description
Position Summary: AstraZeneca is seeking an experienced and highly motivated individual to join its Clinical Pharmacology and Quantitative Pharmacology Department.   The candidate will be responsible for developing immunogenicity assessment strategies for clinical trials of biotherapeutics and working with drug development teams on the data interpretation and report generation.  The individual will work with Statisticians, Clinicians, Patient Safety, Clinical Pharmacology and Bioanalytical Scientists to interpret and report clinical immunogenicity data, including assessment of the potential impact of anti-drug antibodies (ADA) to pharmacokinetics, pharmacodynamics, safety and efficacy of the biologic. Candidate will work with the team on clinical study reports (CSRs), regulatory documents such as the Integrated Summary of Immunogenicity and publications. The candidate will also participate in an internal multidisciplinary group that reviews literature, guidelines and internal proposals concerning immunogenicity assessments. The individual may also assist with work on PD and/or mechanistic markers derived from clinical trials and/or collaborative studies.  
• Knowledge of regulatory guidelines regarding immunogenicity assessment and on the development/execution of bioanalytical assays for PK, PD and ADA and neutralizing antibody (nAb) assessments
• Past experience in interpreting immunogenicity data, preferably including assessment on the potential impact of ADA to PK/PD, safety and efficacy.
• Experience in reviewing or authoring regulatory submission documents and addressing regulatory inquiries is preferred.
• Publication record on immunogenicity-related topics is desirable.
• Ability to multitask and to interact with scientists of multiple disciplines as well as non-scientists.
• Ability to work with both internal and external teams in a time-efficient manner to meet objectives and time lines.  Ability to troubleshoot.
• Strong interpersonal skills and excellent verbal and written communication skills.
Requirements: Ph.D./MS in Immunology, Pharmacology or related discipline preferably with industrial experience in large molecule drug development. 

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.

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