Associate Director, Bioanalytics

• Develop and execute bioanalytical strategies to support discovery, nonclinical, and clinical development programs.
• Serve as the bioanalytical lead on cross-functional project teams.
• Contribute to overall development strategy, timeline planning, and risk assessment activities.

• Identify, select, and manage CROs and laboratory service providers.
• Oversee bioanalytical method development, qualification, validation, transfer, and sample analysis activities.
• Review study plans, protocols, validation reports, and analytical data packages.
• Ensure timely delivery of high-quality data and compliance with project timelines and budgets.

• Ensure bioanalytical activities are conducted in accordance with GLP, GCP, and applicable regulatory guidance.
• Author and review bioanalytical sections of regulatory submissions, including INDs, CTAs, briefing packages, IBs, and NDAs.
• Support regulatory agency interactions and responses related to bioanalytical methodologies and data.
• Collaborate with Quality Assurance to oversee inspections, audits, deviations, investigations, and CAPAs.

• Collaborate with Clinical Pharmacology, DMPK, and Biomarker teams to integrate bioanalytical findings into study and program assessments.
• Present results and recommendations to project teams, senior leadership, and external stakeholders.

• Establish strong partnerships across Research, Development, Clinical, Regulatory, and CMC functions.
• Mentor junior scientists and contribute to the growth of bioanalytical capabilities within the organization.
• Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement.

• D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Pharmacology, or a related scientific discipline with 8+ years of relevant industry experience; or
• S. degree with 12+ years of relevant industry experience; or
• S. degree with 15+ years of relevant industry experience.

• Significant bioanalytical experience supporting drug discovery and development for small molecule programs in the biotechnology or pharmaceutical industry.
• Demonstrated expertise 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.
• Proven ability to influence cross-functional teams and manage multiple programs simultaneously.

P referred Qualifications

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

• Strategic thinking and scientific leadership
• Strong project management and organizational skills
• Excellent written and verbal communication abilities
• Collaborative and team-oriented mindset
• Sound judgment and decision-making
• Ability to thrive in a fast-paced, entrepreneurial biotech environment