Kailera Therapeutics, Inc.
Therapies
AssociateDirector,BioanalyticalSciences
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“Associate Director, Bioanalytical Sciences at Kailera Therapeutics, Inc.. Skills: Bioanalytical strategy, Regulated bioanalysis, CRO management. Design bioanalytical strategy. Execute bioanalytical strategy”
Industry & Context.
What They're Looking For.
Must Have
10+ years of relevant industry experience in bioanalytical sciences with a Bachelor’s degree, 5+ years with an advanced degree, Expertise in regulated bioanalysis, Clinical-stage drug development, In-depth knowledge of GLP/GCP requirements, Industry best practices in bioanalytical laboratories, Proven experience in the regulatory requirements for method development and validation, Track record of managing CRO-outsourced bioanalysis and vendor relationships, Excellent project management skills, Ability to manage multiple priorities effectively, Experience with regulatory interactions, Experience contributing to regulatory filings for biologics and small molecules, Bachelor's degree in a relevant scientific discipline
Nice to Have
PhD preferred, Experience with GLP-1 receptor agonists, Related therapeutic areas, Understanding of bioanalytical considerations for incretin-based therapies
What You'll Do.
Design bioanalytical strategy
Execute bioanalytical strategy
Oversee GLP-compliant bioanalysis
Manage outsourced bioanalysis
Advance drug candidates
Develop bioanalytical assays
Validate bioanalytical assays
Implement bioanalytical assays
Author regulatory submissions
Review regulatory submissions
How You'll Work.
Team & Collaboration
Partner with cross-functional teams; Represent bioanalytical function in project teams
Process & Methodology
Project management skills, Manage multiple priorities
Full Job Description
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 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
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