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

• 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