Associate Director, Bioanalysis

Location: Hybrid 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 on 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, analytical data packages, and project deliverables.
• Support regulatory submissions and agency interactions related to bioanalytical methods and data.
• Collaborate with Clinical Pharmacology, Biomarkers, Toxicology, DMPK, Clinical Operations, Regulatory Affairs, Quality, Research, Development, and CMC teams; mentor junior scientists and present recommendations to stakeholders.

Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Pharmacology, or a related scientific discipline with 8+ years of relevant industry experience; or an M.S. degree with 12+ years; or a B.S. degree with 15+ years.
• Significant bioanalytical experience supporting drug discovery and development for small molecule programs in the biotechnology or pharmaceutical industry.
• Demonstrated experience managing outsourced bioanalytical activities.
• Extensive experience with LC-MS/MS methodologies for small molecule quantitation.
• Strong understanding of FDA, EMA, and ICH bioanalytical method validation guidance.
• Experience supporting regulatory filings and interactions.
• Ability to influence cross-functional teams and manage multiple programs simultaneously.
• Strategic thinking, scientific leadership, project management, organization, written and verbal communication, collaboration, sound judgment, and decision-making skills.
• Ability to work effectively in a fast-paced, entrepreneurial 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 with ligand binding assays, biomarker assay platforms, and both small molecule and biologic drug development programs.

Culture & Benefits

• Hybrid work arrangement in Thousand Oaks or San Francisco.
• Work in an entrepreneurial biotechnology environment focused on scientific excellence, patient focus, innovation, accountability, collaboration, and continuous improvement.
• Opportunity to contribute to the growth of bioanalytical capabilities and mentor junior scientists.