Clinical Immunogenicity Lead

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About the role

The Clinical Immunogenicity Lead is a strategic, scientific, and operational role within Research and Development (R&D). 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.

You will oversee 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 may also be nominated as DMPK Lead for projects and due diligence.

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

Responsibilities

• Drive immunogenicity strategies and risk assessment across bioanalytical activities, ADA data analysis, and regulatory documentation.
• Develop and validate immunogenicity assays, interpret ADA data, and assess clinical impact.
• Prepare IND/BLA sections related to immunogenicity for regulatory submissions.
• Collaborate with translational science, clinical pharmacology, biostatistics, pharmacovigilance, and regulatory teams.
• Oversee clinical bioanalytical work conducted by external partners, ensuring methodological robustness and compliance.
• Coordinate validation of bioanalytical assays related to immunogenicity and PK assessments.
• Perform quality reviews of bioanalytical data and reports.
• Provide troubleshooting support for studies.
• Serve as DMPK Lead for projects and due diligence as needed.
• Present complex immunogenicity data to cross-functional teams and senior management.

Requirements

• 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.
• In-depth understanding of immunogenicity strategies across different modalities.

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 interacting with Health Authorities.
• General knowledge of disease areas such as Immunology and Oncology, along with an understanding of biology and pharmacology.
• Experience managing external partners and CROs for immunogenicity assay work.
• Ability to present complex immunogenicity data to cross-functional teams and senior management.
• Knowledge of emerging industry trends, best practices, and regulatory expectations.
• Excellent organizational and communication skills, with fluency in spoken and written English.
• Strong intercultural awareness.
• Mature leadership and influencing skills.

Schedule

Hybrid, 3x/week in office, Billerica MA.

Pay

The pay range for this position is $126,900 - $215,400. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. The position may be eligible for sales or performance-based bonuses.

Benefits

• Health insurance.
• Paid time off (PTO).
• Retirement contributions.
• Other perquisites.

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