Skip to main content

Search jobs

Search jobs

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Scientist I, Translational Immunology

Irvine, California Req ID 2202774 Category Research and Development Division AbbVie

Senior Scientist I – Translational Immunology

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:

Qualifications

  • PhD in pharmacology, immunology, biology specializing in biotherapeutics, vaccine, or related field with 2-4 years of post-graduate work experience. Biologics drug development experience in a pharmaceutical or biotech industry setting is required.
  • Demonstrated expertise in ocular or dermal immunology is highly desired
  • Expertise in gene therapy is desired.
  • Understanding of immunogenicity monitoring strategies and commonly-used bioanalytical assays is required
  • Broad understanding of clinical implications associated with anti-drug or anti-device immunogenicity responses
  • Strong analytical skills and proficient at complex data analysis and interpretation
  • Must have strong communication skills and the ability to effectively communicate with both internal and external stakeholders, and to audiences of diverse backgrounds
  • Highly motivated, self-driven and results-oriented person, comfortable working independently in a fast-paced environment
  • Demonstrate high degree of flexibility in adapting to different projects and personalities as well as excellent networking and relationship-building skills (both internal and external)
  • Previous hands-on experience with a variety of human immune cell functional in vitro assays (e.c. PBMC, T-cell proliferation, etc.) is desired
Significant Work Activities: N/A
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Research and Development, Irvine, California, United StatesRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation