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 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
- Ability in presenting 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
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. For more information click here.
