Associate Director, Bioanalytical Sciences

What You’ll Do:

The Associate Director, Bioanalytical Sciences at Kailera Therapeutics will report to the Director, Bioanalytical Sciences and will be responsible for designing and executing bioanalytical strategies to support development programs for patients with obesity-related diseases. This role will oversee GLP-compliant bioanalytical work for non-clinical and clinical studies. The Associate Director will manage CRO-outsourced bioanalysis to advance drug candidates through various development stages while partnering with cross-functional teams to ensure the seamless integration of data into Kailera’s broader development programs.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

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