Associate Director, Bioanalytical Sciences

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You'll Do :

The Associate Director, Bioanalytical Sciences at Kailera Therapeutics will report to the VP of Translational Medicine and will be responsible for designing and executing bioanalytical strategies to support development programs for patients with diabetes and obesity-related diseases. This role will oversee GLP-compliant bioanalytical work, including pharmacokinetic (PK) analysis, anti-drug antibody (ADA) / immunogenicity assays, and biomarker assessments for nonclinical 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 PK, immunogenicity, and biomarker strategies into Kailera's broader development programs.

Preferred location : Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities :

• Lead bioanalytical strategy and execution for PK, ADA, and biomarker analysis in clinical and nonclinical 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, ADAs, and biomarkers.
• Direct the development, validation, and implementation of bioanalytical assays for PK, ADA, and biomarker analysis.
• 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 PK, ADA, and biomarker bioanalysis in both nonclinical and clinical trials.
• Author and review bioanalytical sections of regulatory submissions.
• Represent the bioanalytical function in cross-functional project teams and regulatory discussions.

Required Qualifications :

Preferred Qualifications :

Education :

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

Salary Range

160,000-$200,000 USD

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.

E-Verify :

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

LI-Hybrid

Salary : $160,000 - $200,000