Associate Director, Bioanalytical Sciences

Responsibilities:

• Lead bioanalytical strategy and execution in clinical and non-clinical studies
• Collaborate with cross-functional teams to design and implement bioanalytical aspects of clinical development programs
• Identify, select, and oversee CROs, ensuring adherence to timelines, budgets, and regulatory requirements
• Manage and oversee outsourced bioanalysis of small molecules, peptides, and biomarkers
• Direct the development, validation, and implementation of bioanalytical assays
• 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 for bioanalysis in both non-clinical and clinical trials
• Author and review bioanalytical sections of regulatory submissions
• Represent the bioanalytical function in cross-functional project teams
• Required Qualifications:
• 10+ years of relevant industry experience in bioanalytical sciences with a Bachelor’s degree or 5+ years with an advanced degree
• Expertise in regulated bioanalysis and clinical-stage drug development
• In-depth knowledge of GLP/GCP requirements and industry best practices in bioanalytical laboratories
• Proven experience in the regulatory requirements for method development and validation
• 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
• Experience contributing to regulatory filings for biologics and small molecules
• Preferred Qualifications:
• Experience with GLP-1 receptor agonists or related therapeutic areas
• Strong understanding of bioanalytical considerations for incretin-based therapies
• Education:
• Bachelor's degree in a relevant scientific discipline required (e.g., bioanalytical chemistry, pharmacology, or related field); PhD preferred
• 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, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.
• EQUAL 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.
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