Associate Director, Bioanalytical Sciences

Associate Director, Bioanalytical Sciences

Waltham, Massachusetts

At Kailera, we are committed to developing therapies that empower people to transform their lives and improve overall health. We are an entrepreneurial, team‑oriented organization working to advance novel obesity and related condition treatments.

As we expand, we seek diverse talent to join our inclusive workplace built on collaboration, integrity, and excellence.

The Associate Director will report to the Director, Bioanalytical Sciences and 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, manage CRO‑outsourced bioanalysis, and partner with cross‑functional teams to integrate data into the broader development programs.

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 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
• Ensure 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

• 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 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

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

• Bachelor’s degree in a relevant scientific discipline required (e.g., bioanalytical chemistry, pharmacology, or related field);
  PhD preferred

$159,000 - $195,000 USD

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 offer comprehensive health coverage, flexible time off, paid holidays, a year‑end shutdown, a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, annual bonus opportunities, and equity grants.

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of any characteristic protected by applicable federal, state, or local laws.

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