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Director, Immunogenicity Assessment

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Kailera Therapeutics

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Location:
United States , Waltham

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

175000.00 - 230000.00 USD / Year
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Job Description:

The Director, Immunogenicity Assessment at Kailera Therapeutics will report to the Vice President of Translational Medicine and will be responsible for the execution of immunogenicity assessments to support development programs for patients with obesity-related diseases. This role will oversee GLP-compliant bioanalytical work for anti-drug antibody (ADA)/immunogenicity assays and support immunogenicity assessments for non-clinical and clinical studies. The Director will manage CRO-outsourced ADA bioanalysis to advance drug candidates through various development stages while partnering with cross-functional teams to ensure seamless integration into Kailera’s broader development programs.

Job Responsibility:

  • Lead bioanalytical strategy and execution for ADA analysis in clinical and non-clinical studies
  • Collaborate with cross-functional teams to design and implement bioanalytical aspects of clinical development programs
  • Manage cross-functional immunogenicity risk assessments
  • Identify, select, and oversee CROs, ensuring adherence to timelines, budgets, and regulatory requirements
  • Manage and oversee outsourced bioanalysis of ADAs
  • Direct the development, validation, and implementation of bioanalytical assays for ADAs
  • Review validation protocols, test procedures, raw data, and technical reports to ensure scientific rigor and compliance with regulatory guidelines
  • Provide leadership in ensuring GLP compliance in both non-clinical and clinical trials
  • Integrate ADA results with PK/PD, efficiency, and safety data to assess impact on drug exposure and outcomes
  • Provide expert input into clinical study reports, regulatory submissions, and risk management plans
  • Author and review immunogenicity sections of INDs, BLAs/MAAs, and briefing documents
  • Represent the company in regulatory agency meetings, addressing immunogenicity strategy and assay performance

Requirements:

  • 10+ years of relevant experience
  • Expertise in regulated bioanalysis and clinical-stage drug development
  • In depth knowledge of GLP/GCP requirements and industry best practices in bioanalysis laboratories
  • Proven experience in regulatory requirements for method development and validation of immunogenicity assays
  • Strong track record of managing CRO-outsourced bioanalysis and vendor relationships
  • Excellent project management skills with the ability to manage multiple priorities effectively
  • Experience with regulatory interactions is highly desirable
  • Hands on experience contributing to regulatory filings
  • PhD in relevant scientific discipline (e.g. bioanalytical chemistry, immunology, pharmacology, or related field)

Nice to have:

  • Experience with GLP-1 receptor agonists or related therapeutic areas
  • Strong understanding of bioanalytical considerations for incretin-based therapies
What we offer:
  • Comprehensive health coverage
  • Flexible time off
  • Paid holidays
  • Year-end shutdown
  • Monthly wellness stipend
  • Generous 401(k) match
  • Tuition reimbursement
  • Commuter benefits
  • Disability and life insurance
  • Annual bonus opportunities
  • Equity grants

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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