Associate Director, Bioanalytics

Location: Hybrid role based in Thousand Oaks, California or San Francisco, California

Company

hirify.global is an early-stage biotechnology company developing non-opioid medicines for pain and pain-related syndromes.

What you will do

• Develop and execute bioanalytical strategies for discovery, nonclinical, and clinical development programs.
• Lead bioanalytical activities across cross-functional project teams and contribute to development strategy, timelines, and risk assessments.
• Select and manage CROs and laboratory service providers, overseeing assay development, qualification, validation, transfer, and sample analysis.
• Review study plans, protocols, validation reports, and analytical data packages while ensuring delivery against budgets and timelines.
• Integrate bioanalytical findings with Clinical Pharmacology, DMPK, Biomarkers, Toxicology, Clinical Operations, Regulatory Affairs, Quality, and CMC teams.
• Present results to project teams and senior leadership, mentor junior scientists, and support the growth of bioanalytical capabilities.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Pharmacology, or a related discipline with 8+ years of relevant industry experience; or an M.S. with 12+ years; or a B.S. with 15+ years.
• Significant bioanalytical experience supporting small-molecule drug discovery and development in biotechnology or pharmaceutical settings.
• Extensive experience with LC-MS/MS methodologies for small-molecule quantitation and outsourced bioanalytical activity management.
• Strong understanding of FDA, EMA, and ICH bioanalytical method validation guidance, including GLP and GCP requirements.
• Experience supporting regulatory filings, agency interactions, audits, inspections, deviations, investigations, and CAPAs.
• Ability to influence cross-functional teams and manage multiple programs simultaneously in a fast-paced biotech environment.

Nice to have

• Experience supporting Phase 1 through Phase 3 clinical studies.
• Experience with pain, neuroscience, ion channel, or CNS drug development programs.
• Experience supporting biologic drug development programs.

Culture & Benefits

• Science-, patient-, and innovation-focused environment.
• Collaborative work across Research, Development, Clinical, Regulatory, and CMC functions.
• Emphasis on scientific excellence, accountability, continuous improvement, and team development.