Associate Director, Bioanalytical Sciences

The role

The Associate Director, Bioanalytical Sciences will design and execute bioanalytical strategies to support development programs for obesity-related diseases. This role oversees GLP-compliant bioanalytical work and manages CRO-outsourced bioanalysis.

What you will do

• 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
• 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
• 5 years of hands-on experience in MD/MV of LC/MS/MS assays
• 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 contributing to regulatory filings for biologics and small molecules
• Bachelor's degree in a relevant scientific discipline (e.g., bioanalytical chemistry, pharmacology, or related field)

Nice to have

• Experience with regulatory interactions
• Experience with GLP-1 receptor agonists or related therapeutic areas
• Strong understanding of bioanalytical considerations for incretin-based therapies
• PhD

Benefits

• 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

Before you apply

• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company has an entrepreneurial spirit and a team-oriented culture.