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Bioanalytical Study Lead Jobs (NOW HIRING)

CEDENT

Senior Scientist, Bioanalytical Sciences

Cambridge, MA · On-site

$100K - $136K/yr

In this hands-on, lab-based role, you will lead the design, development, and execution of regulatory-aligned bioanalytical assays supporting IND-enabling studies for our mRNA-LNP therapeutics. You ...

MBX Biosciences

Director, Bioanalytical

Burlington, MA · On-site

... studies through pivotal clinical development. Key responsibilities include: * Provide strategic ... Lead bioanalytical activities for pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity (ADA ...

RPM ReSearch

LCMS Scientist

Columbia, MO · On-site

This is a hands-on role within a GLP-regulated environment, supporting bioanalytical studies from ... Prior team lead or mentoring experience * Exposure to client-facing work * Experience with Shimadzu ...

BioAge

Lead the Drug Metabolism and Pharmacokinetics (DMPK) and translational pharmacology strategy across ... and bioanalytical studies to enable informed candidate selection and progression decisions.

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As of Sep 13, 2026, the average hourly pay for bioanalytical study lead in the United States is $25.39, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $27.88 per hour, depending on experience, location, and employer.

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Infographic showing various Bioanalytical Study Lead job openings in the United States as of July 2026, with employment types broken down into 88% Full Time, 9% Part Time, and 3% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $52,817 per year, or $25.4 per hour.

Associate Director, Bioanalytical Sciences

Waltham, MA • On-site

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

Full-time

Re-posted 24 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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