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Director Bioanalytical Method Development Jobs (NOW HIRING)

Otsuka

Associate Director, Bioanalysis

The Associate Director, Bioanalysis is responsible for providing strategic and scientific oversight ... Oversee bioanalytical method development, qualification, validation, and sample analysis activities ...

Posted today

MSD

Director, Bioanalytical Laboratory

Gaithersburg, MD · On-site

$114K - $149K/yr

... directing the resources of a bioanalytical laboratory performing assay validations and sample ... methods developed and used in the laboratory. DUTIES AND RESPONSIBILITIES: • Responsible for ...

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How much do director bioanalytical method development jobs pay per year?

As of Sep 11, 2026, the average yearly pay for director bioanalytical method development in the United States is $191,412.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $249,000.00 per year, depending on experience, location, and employer.

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Associate Director, Bioanalytical Sciences

Waltham, MA • On-site

Kailera Therapeutics, Inc.
See more jobs at Kailera Therapeutics, Inc.external

Full-time

Re-posted 22 days ago

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

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