Director, Immunogenicity Assessment

divh2Director, Immunogenicity Assessment/h2pAt 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 Kaileras 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./ppThe 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 Kaileras broader development programs. Required location: Waltham, MA (hub-based, onsite 3-4 days per week)/ppResponsibilities:/pulliLead bioanalytical strategy and execution for ADA analysis in clinical and non-clinical studies/liliCollaborate with cross-functional teams to design and implement bioanalytical aspects of clinical development programs/liliManage cross-functional immunogenicity risk assessments/liliIdentify, select, and oversee CROs, ensuring adherence to timelines, budgets, and regulatory requirements/liliManage and oversee outsourced bioanalysis of ADAs/liliDirect the development, validation, and implementation of bioanalytical assays for ADAs/liliReview validation protocols, test procedures, raw data, and technical reports to ensure scientific rigor and compliance with regulatory guidelines/liliProvide leadership in ensuring GLP compliance in both non-clinical and clinical trials/liliIntegrate ADA results with PK/PD, efficiency, and safety data to assess impact on drug exposure and outcomes/liliProvide expert input into clinical study reports, regulatory submissions, and risk management plans/liliAuthor and review immunogenicity sections of INDs, BLAs/MAAs, and briefing documents/liliRepresent the company in regulatory agency meetings, addressing immongenicity strategy and assay performance/li/ulpRequired Qualifications:/pulli10+ years of relevant experience/liliExpertise in regulated bioanalysis and clinical-stage drug development/liliIn depth knowledge of GLP/GCP requirements and industry best practices in bioanalysis laboratories/liliProven experience in regulatory requirements for method development and validation of immunogenicity assays/liliStrong track record of managing CRO-outsourced bioanalysis and vendor relationships/liliExcellent project management skills with the ability to manage multiple priorities effectively/liliExperience with regulatory interactions is highly desirable/liliHands on experience contributing to regulatory filings/li/ulpPreferred Qualifications:/pulliExperience with GLP-1 receptor agonists or related therapeutic areas/liliStrong understanding of bioanalytical considerations for incretin-based therapies/li/ulpEducation:/pulliPhD in relevant scientific discipline (e.g. bioanalytical chemistry, immunology, pharmacology, or related field)/li/ulpSalary Range: $175,000 - $230,000 USD/ppThis range represents the companys 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, plus annual bonus opportunities and equity grantsbecause your well-being and future matter to us./ppEqual Employment Opportunity Information: Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances./ppE-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires./p/div