Immunogenicity Strategy Lead — Biotherapeutics R&D

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

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.