Associate Director, Bioanalytical Sciences

Responsibilities

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

Requirements

• 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
• Salary Range
• $159,000 - $195,000 USD
• EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
• E-Verify:
• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
• #LI-Hybrid

Benefits

Additional Information

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.

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