What You'll DoThe Director of Bioanalytical Sciences at MBX Biosciences is expected to provide strategic, scientific, and operational leadership for the development, validation, and execution of bioanalytical strategies that support the company's portfolio of precision peptide therapeutics across discovery, preclinical, and clinical development stages. This role is responsible for ensuring the generation of high-quality pharmacokinetic (PK), anti-drug antibody (ADA), immunogenicity, pharmacodynamic (PD), and biomarker data to advance MBX's innovative endocrine and metabolic disease programs and meet global regulatory requirements. The Director partners closely with Research, Clinical Development, Clinical Pharmacology, Regulatory Affairs, CMC, Quality, and external CRO partners to drive efficient program execution and data integrity. The ideal candidate combines deep expertise in large molecule and peptide bioanalysis with strong leadership, vendor management, and cross-functional collaboration skills, enabling the successful progression of candidates from IND-enabling studies through pivotal clinical development. Key responsibilities include:
- Provide strategic leadership for bioanalytical assay development, validation, transfer, and execution to support discovery, preclinical, and clinical-stage peptide therapeutic programs.
- Lead bioanalytical activities for pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity (ADA/NAb), and biomarker assessments across MBX's endocrine and metabolic disease portfolio.
- Develop and implement phase-appropriate bioanalytical strategies that ensure compliance with FDA, EMA, ICH, and other global regulatory requirements.
- Serve as the bioanalytical subject matter expert on cross-functional project teams, partnering closely with Research, Clinical Development, Clinical Pharmacology, Regulatory Affairs, CMC, and Quality functions.
- Oversee external CROs and laboratory partners, ensuring high-quality data delivery, adherence to timelines, budget management, and operational excellence.
- Review, interpret, and communicate bioanalytical, PK, immunogenicity, and biomarker data to support key development, regulatory, and portfolio decision-making.
- Drive authoring and review of regulatory submissions and supporting documentation, including INDs, clinical study reports, bioanalytical reports, and responses to health authority inquiries.
- Build, mentor, and develop high-performing bioanalytical teams while fostering a culture of scientific rigor, collaboration, innovation, and continuous improvement.
- Identify and implement emerging bioanalytical technologies and best practices to enhance data quality, operational efficiency, and the successful advancement of MBX's precision peptide therapies.
- Other responsibilities as assigned.
What You Bring- MS with 9+ years of experience or PhD in a relevant field with 7+ years of bioanalytical experience in biotech/pharma, including leadership responsibility supporting preclinical and clinical development programs.
- Deep expertise in LC-MS/MS, biomarker assays, and immunogenicity testing for peptides and small molecules.
- Proven experience in bioanalytical method development and validation.
- Strong knowledge of GLP, GCLP and bioanalytical regulatory guidance (ICH M10) and experience supporting regulatory submissions.
- Experience managing CROs and external bioanalytical laboratories, including assay transfer, validation oversight, troubleshooting and vendor governance.
- Demonstrated leadership in supporting early and late-stage clinical development programs, including Phase I-III studies and IND/BLA/NDA support.
- Experience with metabolic disease, obesity, endocrinology, and peptide therapeutics is highly desirable.
- Excellent strategic communication and data interpretation skills, including presentation to executive leadership, health authorities, and external partners.
- Proven people-management and organizational leadership capability, including mentoring scientists and building scalable bioanalytical operations in a growth-stage biotech environment.
Travel & In Office Presence You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.
