Director, Immunogenicity Assessment

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: 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. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: 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 immongenicity strategy and assay performance Required Qualifications: 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 Preferred Qualifications: Experience with GLP-1 receptor agonists or related therapeutic areas Strong understanding of bioanalytical considerations for incretin-based therapies Education: PhD in relevant scientific discipline (e.g. bioanalytical chemistry, immunology, pharmacology, or related field) Salary Range $196,000 $240,000 USD For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, ... (truncated, view full listing at source)