Clinical Immunogenicity Lead

EMD Serono, Inc.; Billerica (MA); Hybrid; USD 140,000 - 210,000; Full time

Job summary

EMD Serono, Inc. is seeking a Clinical Immunogenicity Lead to drive immunogenicity strategies across bioanalytical activities and regulatory documentation.

The role oversees external partners for immunogenicity assay work, coordinates IND/BLA sections, and collaborates with translational science, clinical pharmacology, and biostatistics to ensure robust data and regulatory readiness. Hybrid work with 3 days/week in office in Billerica, MA.

Qualifications

• Ph.D. required in Biochemistry, Biology, Chemistry, or related field.
• 5+ years in pharma or CRO in similar roles.
• Deep experience with NBEs, ADCs, and other novel modalities in the clinical space.

Responsibilities

• Lead immunogenicity strategies and risk assessment across bioanalytical activities and regulatory documentation.
• Oversee external partners for immunogenicity assay work and regulatory submissions.
• Coordinate validation of bioanalytical assays for immunogenicity and PK assessments.
• Provide troubleshooting and ensure regulatory compliance across studies.

Skills

Immunogenicity strategies

ADA data interpretation

Bioanalytical oversight

External partner management

Regulatory submissions

Education

Ph.D. in Biochemistry, Biology, Chemistry

Tools

GLP/GCP regulations

Job description

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

The Clinical Immunogenicity Lead is a strategic, scientific, and operational role within Research and Development (R&D). EMD Serono is dedicated to delivering transformational medicines to patients, and in this role, you will collaborate within a matrixed environment alongside passionate functional experts to advance novel biotherapeutics.

We are seeking a Clinical Immunogenicity Expert to drive immunogenicity strategies and risk assessment across bioanalytical activities, ADA data analysis, and regulatory documentation. The ideal candidate will have deep experience in immunogenicity assay development/validation, ADA data interpretation and clinical impact, and preparation of IND/BLA sections related to immunogenicity for regulatory submissions.

The role requires strong collaboration with translational science, clinical pharmacology, biostatistics, pharmacovigilance and regulatory. Further, you will be responsible for overseeing the clinical bioanalytical work conducted by external partners, ensuring methodological robustness and compliance with regulatory requirements. Specifically, you will coordinate the validation of bioanalytical assays related to immunogenicity and PK assessments, and perform quality reviews of bioanalytical data and reports. Throughout the studies, you will provide troubleshooting support as needed. You can also be nominated as DMPK Lead for projects and due diligence.

Location

Hybrid, 3x/week in office, Billerica MA

Minimum Qualifications

• Ph.D. in Biochemistry, Biology, Chemistry, or a related field
• 5+ years of experience in the pharmaceutical industry or CRO in comparable roles
• Extensive experience with biological molecules such as NBEs, ADCs, and other novel modalities in the clinical space, with in-depth understanding of immunogenicity strategies across different modalities

Preferred Qualifications

• Extensive background in ligand-binding assays, with preference for experience in cell-based assays
• Strong understanding of immunogenicity and its clinical implications.
• Proficiency in data analysis and integration of ADA data with PK/PD and safety data.
• In-depth knowledge of GLP/GCP regulations
• Experience supporting regulatory submissions, including authoring Integrated Summary of Immunogenicity, Clinical Study Reports (CSRs), summary sections for INDs, Investigator’s Brochures (IBs), briefing books, and BLAs
• Experience in interaction with Health Authorities
• General knowledge of disease areas such as Immunology and Oncology, along with an understanding of biology and pharmacology
• Experience in managing external partners and CROs for immunogenicity assay work