Director, Quality (Clinical)

Key responsibilities

• Quality Strategy & Leadership
• GCP/GLP Quality Oversight
• Oversight & Compliance
• Data Integrity & Clinical Data Quality
• Cross-Functional Collaboration

Required experience & skills

• Bachelor’s degree in life sciences, health sciences or related discipline; advanced degree preferred
• At least 10 years of GxP quality experience, including deep experience in GCP oversight and global clinical development
• Strong knowledge of global GxP regulations (GCP, GLP, GMP, GVP, GDP as applicable) and regulatory expectations for late-stage clinical programs
• Proven success establishing and executing clinical and nonclinical oversight in a small or emerging biotech environment
• Experience developing audit strategies, overseeing vendors and CROs, and supporting inspection readiness and regulatory interactions
• Experience developing clinical quality oversight plans, including study, CRO, site, system, and focused data evaluation
• Demonstrated ability to independently assess complex clinical quality issues and develop well-supported recommendations that are scientifically, operationally, and regulatorily sound.
• Demonstrated ability to evaluate clinical data integrity, endpoint reliability, documentation quality, monitoring effectiveness, vendor data flows, and inspection readiness of clinical trial data.
• Demonstrated experience with computerized system validation for clinical and nonclinical systems in a regulated environment
• Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Strong quality judgment, including the ability to identify material clinical quality risks, escalate appropriately, and drive issues to resolution across functions and external partners.
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred experience & skills

• Experience in rare disease, cardiovascular, or specialty disease clinical development
• Experience supporting preparation for major regulatory submissions (NDA/BLA/MAA)
• Experience with nonclinical quality oversight, GLP compliance, or nonclinical vendor oversight
• Working knowledge of GDPR and clinical trial data privacy requirements
• Audit and/or quality certification (e.g., CQA, RQAP-GCP, ISO Lead Auditor)
• Experience with ICH E6(R3), risk-based quality management, centralized monitoring, quality tolerance limits, and critical-to-quality factors
• Experience evaluating CRO and vendor data integrity, including data transfers and transformations

Pay

Base Salary Range: $195,000 - $230,000