Clinical Immunogenicity Subject Matter Expert

Date:  Feb 25, 2024
Department:  GRD Biotech Research & Product Development
Job Type:  Direct Employee
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Contract Type:  Permanent
Location: 

Italy or anywhere in Europe, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. 

 

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.  Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).

 

Who we are looking for

Purpose

•    Provides expertise in immunogenicity evaluations of biopharmaceuticals in R&D
•    Defines the tiered immunogenicity testing strategy with respect to risk and safety aspects
•    Contributes to study design, provides clinical data interpretation regarding the impact of immunogenicity on safety and efficacy, and the overall benefit-risk profile of a compound
•    Develops high quality regulatory documentation and respond to regulatory questions regarding immunogenicity 
 

Main Responsibilities

•    Provides in-depth knowledge of clinical immunology, immunogenicity analytical methods and the interpretation and communication of clinical immunogenicity data. 
•    Develops and implements immunogenicity assessment strategies for biologic therapeutic throughout the drug development process
•    Sets Immunogenicity analytical strategy (ensuring correct assays and reagents applied according to immunogenicity risk) for core teams at early phases and updates as required
•    Provides deep scientific and technical knowledge of the nature of an immunological response to set-up, optimize and trouble shoot  relevant characterization methods (neutralization of the therapeutic action and domain specificity)
•    Provides expert recommendations regarding study design, protocol development and reporting format (e.g. sampling, assays, tables, figures and listings) for immunogenicity testing components
•    Responsible for immunogenicity clinical data interpretation and assessing as well as communicating impact of data on benefit-risk profile of an asset 
•    Develops and defends regulatory documentation (e.g. integrated summary of immunogenicity and responses to regulatory questions)
•    Maintains high level of knowledge on latest and any evolving regulatory guidance and expectations regarding immunogenicity testing 
•    Works closely with Clinical Programs and other Clinical functions in ensuring immunogenicity objectives in a study and program are met in a timely fashion and of high quality 
•    Collaborates effectively with Early Research and Pre-clinical Research informing translation of pre-clinical data into early clinical immunogenicity risk assessment and predicting human immunogenic response
•    Works together with the CMC to establish the correlation between structural elements of the biopharmaceutical and its expected immunogenic profile in animals and patients 
•    Supports due diligence assessments for biopharmaceuticals and prospective acquisitions
•    Contribute to scientific publications, abstracts, and presentations at conferences, representing the company's expertise in immunogenicity assessments to the scientific community and external bodies
•    Maintains high standards and levels of scientific and clinical knowledge in the relevant therapeutic and disease area(s) 
    KPIs

Experience Required

•    Proven track record of at least 5 years of industry experience in immunogenicity assessment within the biopharmaceutical or biotechnology industry 

Education

•    Ph.D. in Immunology, Biochemistry, Pharmacology, or a related field. Post-doctoral training in immunogenicity assessment is highly desirable.

Languages

English Fluent

Technical Skills

•    Expertise in designing and executing immunogenicity studies, including the development and validation of immunogenicity assays.
•    Technical expertise in generation of critical reagents including phage display and B cell sorting
•    Strong understanding of immunology principles, immune responses to biologics, and the factors influencing immunogenicity.
•    Experience with data analysis, including statistical methods and bioinformatics tools applied to immunogenicity data.
•    Familiarity with regulatory requirements and guidelines for immunogenicity assessment in drug development (e.g., FDA, EMA).
•    Strong publication record in the field of immunogenicity assessment is preferred.

Soft Skills

  • Analytical skills
  • Communication skills
  • Problem solving
  • Team working
  • Goal orientation

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

Discover all our opportunities