Associate Director, Preclinical Bioanalytical Science

Responsibilities

• Partner with line management, nonclinical toxicologists, discovery biology, and clinical pharmacologists to align bioanalytical activities with program needs.
• Serve as the preclinical bioanalytical lead and subject matter expert on cross-functional program teams, representing bioanalytical and biomarker strategy, scientific rationale, and key deliverables.
• Define bioanalytical and biomarker method selection criteria, ensuring assays are fit for purpose and aligned with scientific objectives and program timelines.
• Contribute bioanalytical perspective to diligence on external assets and potential in-licensing opportunities.
• Apply deep technical judgment and adaptability to solve problems, prioritize effectively, and deliver under tight timelines and evolving scope.
• Select and manage external vendors for outsourced bioanalytical and biomarker projects, including oversight of scope, deliverables, and timelines.
• Oversee outsourced assay development, qualification, and validation across LCMS, ELISA, RT-qPCR, immunogenicity, and cell-based platforms, ensuring methods meet regulatory expectations for preclinical programs.
• Review bioanalytical method development, validation, and sample analysis reports in collaboration with nonclinical toxicology and clinical pharmacology partners.
• Troubleshoot bioanalytical method issues, support CAPA activities when needed, and manage critical reagent lifecycle risks across program timelines.
• Excellent communication and collaboration skills and ability to work with cross-functional scientists and non-scientists. Ability to convey ideas and opinions clearly, concisely, and with a smile.
• Prepare and organize data for cross-functional presentation. Communicate strategy and results in written and oral reports to various levels of management.
• Communicate research efforts to executive team members, collaborators, and/or at scientific meetings.
• Participate in planning and authoring of regulatory and clinical documents, abstracts, posters, and publications.

Requirements

• Ph.D. in biology, chemistry or a related field with at least 4 years, or MS with at least 6 years of relevant bioanalytical experience in pharma/biotech/CRO environment. At least 2 years’ experience in biotech is non-negotiable. Past CRO experience is a plus.
• Demonstrated experience developing and leading bioanalysis projects in support of preclinical lead nomination and IND-enabling for LCMS, ELISA, RT-qPCR, ADA, and biomarker assays. LCMS experience preferred.
• Demonstrated previous bioanalytical method technical expertise in small molecule, anti-sense oligonucleotides, peptides, biologics and their requisite guidance documents. Expert level technical knowledge is preferred in at least 3 of the 4, with willingness and ability to quickly learn and adapt to new technologies.
• Strong knowledge and experience with application of bioanalytical assay development, qualification/validation and sample analysis as it pertains to preclinical and clinical drug development.
• Strong interpersonal skills as well as excellent communication and presentation abilities.
• Able to function in a biotech team environment by effectively collaborating within and across departments.
• Previous experience contributing to regulatory documents and interacting with health authorities is a plus but not required.