About this opportunity
Kailera Therapeutics, Inc. lists this Associate Director, Bioanalytical Sciences opportunity in waltham, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
What You’ll Do
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)
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 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
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 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 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.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
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.
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Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.