Clinical Immunogenicity Lead

Millipore Corporation; Billerica (MA); Hybrid; USD 127,000 - 215,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Benefits package

Job summary

EMD Serono in the United States seeks a Clinical Immunogenicity Lead to drive immunogenicity strategies and oversee bioanalytical work in R&D. You will collaborate with translational science, clinical pharmacology, biostatistics, pharmacovigilance, and regulatory teams to advance novel biotherapeutics and support regulatory submissions.

You will coordinate external partners for immunogenicity assay work, validate bioanalytical assays, review data, and present complex results to senior

Qualifications

• Ph.D. in Biochemistry, Biology, Chemistry, or related field.
• 5+ years in pharma/CRO in immunogenicity or bioanalytical roles.
• Experience with NBEs, ADCs, and other novel modalities.
• Experience supporting regulatory submissions (INDs/BLAs/CSRs).

Responsibilities

• Lead immunogenicity strategies across bioanalytical activities.
• Oversee external partners/CROs for immunogenicity assay work.
• Coordinate validation of bioanalytical assays for immunogenicity and PK.
• Prepare regulatory documentation sections (IND/BLAs, CSRs).
• Present complex data to cross-functional teams and leadership.

Skills

Immunogenicity strategy leadership

ADA data analysis

Regulatory submissions

External partnerships management

Bioanalytical coordination

Cross-functional collaboration

Data interpretation

Education

Ph.D. in Biochemistry/Biology/Chemistry or related field

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

Who You Are:

Minimum Qualifications:Ph.D. in Biochemistry, Biology, Chemistry, or a related field5+ years of experience in the pharmaceutical industry or CRO in comparable rolesExtensive 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 modalitiesPreferred Qualifications:Extensive background in ligand-binding assays, with preference for experience in cell-based assaysStrong 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 regulationsExperience supporting regulatory submissions, including authoring Integrated Summary of Immunogenicity, Clinical Study Reports (CSRs), summary sections for INDs, Investigator's Brochures (IBs), briefing books, and BLAsExperience in interaction with Health AuthoritiesGeneral knowledge of disease areas such as Immunology and Oncology, along with an understanding of biology and pharmacologyExperience in managing external partners and CROs for immunogenicity assay workAbility in presenting complex immunogenicity data to cross-functional teams and senior managementKnowledge of emerging industry trends, best practices and regulatory expectations Excellent organizational and communication skills, with fluency in spoken and written English Strong intercultural awarenessMature leadership and influencing skills

Pay Range for this position: $126,900 - 215,400 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prequisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!