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Pk Immunogenicity Jobs (NOW HIRING)

Frontage Laboratories, Inc.

$46K - $50K/yr

Position Summary The Scientific Program Manager & Biologics SME will serve as the primary scientific liaison for large molecule bioanalytical programs, including PK, immunogenicity (ADA), cell-based ...

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Merck Group

Clinical Immunogenicity Lead

Billerica, MA · On-site

$126K - $215K/yr

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 ...

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Pk Immunogenicity information

What is the difference between Pk Immunogenicity vs Pharmacokinetic Scientist?

AspectPk ImmunogenicityPharmacokinetic Scientist
Required credentialsTypically requires immunology, pharmacology, or related certificationsRequires pharmacology, biochemistry, or related degrees
Work environmentLaboratories, clinical trial settings, research institutionsLaboratories, clinical research, pharmaceutical companies
Industry usageUsed in biotech and pharma to assess immune responses to biologicsUsed in drug development to analyze drug absorption, distribution, metabolism, and excretion

While both roles are integral to drug development, Pk Immunogenicity focuses on immune responses to biologics, whereas Pharmacokinetic Scientists analyze how drugs move through the body. Understanding these differences helps clarify career paths and industry roles.

What other helpful pages are available for Pk Immunogenicity?

Other pages related to Pk Immunogenicity:

Infographic showing various Pk Immunogenicity job openings in the United States as of September 2026, with employment types broken down into 97% Full Time, and 3% Contract. Highlights an 85% In-person, 5% Hybrid, and 10% Remote job distribution.

Director, Bioanalytical

Burlington, MA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Posted 13 days ago

Job description

What You’ll Do

The Director of Bioanalytical Sciences provides strategic, scientific, and operational leadership for development, validation, and execution of bioanalytical strategies supporting precision peptide therapeutics across discovery, preclinical, and clinical stages.

Key responsibilities:

  • Lead bioanalytical assay development, validation, transfer, and execution.
  • Lead PK, PD, immunogenicity (ADA/NAb), and biomarker assessments.
  • Develop phase-appropriate bioanalytical strategies compliant with FDA, EMA, ICH, and other global requirements.
  • Serve as bioanalytical subject matter expert on cross-functional teams (Research, Clinical Development, Clinical Pharmacology, Regulatory Affairs, CMC, Quality).
  • Oversee external CROs and laboratory partners (data quality, timelines, budget, operational excellence).
  • Review, interpret, and communicate bioanalytical/PK/immunogenicity/biomarker data for development and regulatory decisions.
  • Author/review INDs, clinical study reports, bioanalytical reports, and responses to health authority inquiries.
  • Build, mentor, and develop bioanalytical teams; identify and implement emerging technologies/best practices.
What You Bring
  • MS with 9+ years’ experience or PhD with 7+ years bioanalytical experience in biotech/pharma, including leadership for preclinical/clinical programs.
  • Deep expertise in LC-MS/MS, biomarker assays, and immunogenicity testing for peptides/small molecules.
  • Proven bioanalytical method development and validation experience.
  • Strong knowledge of GLP/GCLP and bioanalytical regulatory guidance (ICH M10).
  • Experience managing CROs/external labs (assay transfer, validation oversight, troubleshooting, vendor governance).
  • Leadership supporting Phase I–III studies and IND/BLA/NDA support.
  • Metabolic disease/obesity/endocrinology/peptide therapeutics experience desirable.
  • Excellent communication/data interpretation; people-management and scalable operations building skills.
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