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Senior Scientist II, Clinical Pharmacology Immunologist

Company: AbbVie
Location: Irvine
Posted on: August 4, 2022

Job Description:

Description
The Clinical Pharmacology group, as part of Research, Nonclinical and Translational Sciences (RNTS) at AbbVie, is searching for an individual with experience in translational immunology to develop risk-based immunogenicity assessment strategies, provide project support, inform decision-making in large molecule and device projects from Discovery to Development to Post Marketing support for assets in the eyecare, aesthetics, and neurotoxin portfolios. The successful candidate will serve as an in-house translational immunology expert and resource programs supporting development of for locally delivered products.
This role will interact and collaborate with diverse functional groups within AbbVie including Research, Toxicology, Immunology, Clinical Pharmacology, Clinical Development, Biostatistics, Regulatory Affairs, and Global Patient Safety and Epidemiology.
Candidates for this position must be able to analyze and understand complex scientific data quickly and condense the information into straightforward, clinically relevant messages for external and internal communication.
Responsibilities
Provide immunology and immunogenicity expertise to biologic drug and device development programs from discovery research to post-marketing in the eyecare, aesthetics, and neurotoxin portfolios
Develop risk-based immunogenicity assessment strategies for novel biologic therapeutics and device projects with a focus on clinical impact
Analyze and interpret immunogenicity data from nonclinical and clinical studies to determine clinical relevance and translatability
Work cross-functionally with statistical and informatics functions to develop analysis plans for interpreting data in the context of safety and efficacy
Lead analysis efforts across clinical trials and biologic programs to better understand emerging immunogenicity trends across modalities, routes of administration, and indications
Develop strategies and best practices for immunogenicity characterization, data handling, and interpretation
Represent the Clinical Pharmacology function on multiple cross-functional development teams and contribute to strategic and scientific planning and execution
Author Immunogenicity sections of regulatory submissions, such as clinical study reports, investigator brochures, and BLA/MAA dossiers, etc.
Present results and key messages of immunogenicity findings to internal teams, executive management, external collaborators, and regulatory authorities
Author immunogenicity-focused publications and present findings at conferences and other public forums
Qualifications:
* PhD with 0-3 years of experience or Pharm D with 2-5 years of experience in a relevant field*; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
* Excellent interpersonal skills
* Ability to interact externally and internally and perform in a team setting
* Demonstrates scientific acumen and has technical skills to perform the role
* Key Leadership Competencies: Persistent and resilient finds the way to move good ideas forward; Uses mistakes, failure and reflection as vehicles for learning and improvement; Delivers business results while also positioning AbbVie for long-term success; Connects unrelated concepts, generates original or unique ideas; Influences colleagues to achieve cross-functional alignmentPDN-ABV2208118

Keywords: AbbVie, Irvine , Senior Scientist II, Clinical Pharmacology Immunologist, Healthcare , Irvine, California

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