Associate Director, Bioanalytical Sciences

Kailera Therapeutics; Boston (MA); On-site; USD 159,000 - 195,000; Full time

Benefits offered by this job

Comprehensive health coverage

Flexible time off

Paid holidays

401(k) match

Tuition reimbursement

Wellness stipend

Equity grants

Job summary

Kailera Therapeutics is seeking an Associate Director, Bioanalytical Sciences in Boston, MA. In this role, you'll design and execute bioanalytical strategies to support development programs for patients with obesity-related diseases. You'll oversee GLP-compliant work and manage CRO-outsourced bioanalysis.

A Bachelor's degree in a relevant field and 10+ years of experience are required, along with expertise in regulated bioanalysis. The position offers a competitive salary range of $159,000—$195,000 and various benefits including comprehensive health coverage and a 401(k) match.

Qualifications

• 10+ years of experience in bioanalytical sciences.
• Strong understanding of clinical-stage drug development.
• Experience with regulatory interactions is highly desirable.

Responsibilities

• Lead bioanalytical strategy and execution in studies.
• Collaborate with teams to implement bioanalytical programs.
• Manage and oversee CROs for bioanalysis.

Skills

Expertise in regulated bioanalysis

Project management skills

Strong track record in managing CRO relationships

Knowledge of GLP/GCP requirements

Education

Bachelor’s degree in a relevant scientific discipline

PhD preferred

Job description

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

Salary Range: $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 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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