The Opportunity
As the Principal Clinical Quality Compliance and Policy Lead, you will serve as a strategic advisor embedded across Early Clinical Development (ECD) study teams. In this leadership role, you will champion a proactive quality culture, translating complex global regulatory requirements into pragmatic, robust clinical compliance strategies that advance our groundbreaking early-stage clinical trial pipeline.
- Drive strategic partnerships across Early Clinical Development (ECD) and global cross-functional stakeholders to align compliance strategy and address high-complexity quality matters.
- Provide strategic quality direction, Good Clinical Practice (GCP) compliance expertise, and proactive risk-mitigation frameworks for early clinical study programs.
- Lead high-impact global initiatives, working groups, and compliance policy development as a key decision-maker and strategic reviewer.
- Oversee Quality Management System (QMS) activities, including deviation management, robust root cause analysis, and strategic Corrective Action/Preventive Action (CAPA) evaluations.
- Direct Health Authority inspection readiness initiatives, Standard Operating Procedure (SOP) optimizations, and strategic response frameworks for global regulatory inspections.
- Establish Key Quality Indicators (KQIs) and compliance metrics to proactively identify systemic trends, mitigate study risks, and drive continuous organizational improvement.
- Champion a robust culture of quality across early development programs through targeted training and strategic compliance communications.
- Manage and lead a team through hiring, strategic direction, oversight, ongoing coaching, regular communication, and performance development.
Who you are
- Education & Foundation: You bring a Bachelor’s degree in life sciences or a related healthcare discipline.
- Industry Experience: You bring a minimum of 7–12 years of progressive experience in pharmaceutical drug development (or 6–8 years with a Master’s; 5–7 years with a PhD, JD, or MD), with focused experience in regulatory compliance or clinical quality assurance.
- GCP & Regulatory Mastery: You possess a minimum of 8 years in a GCP-related discipline or clinical quality assurance role, demonstrating expert-level knowledge of GCP/ICH guidelines, global health authority regulations (e.g., FDA, EMA), and clinical trial best practices.
- Strategic Problem Solver & Matrix Leader: You have a proven track record of strategic problem-solving, matrix leadership, and leading continuous process improvements in complex, fast-paced clinical environments.
- Influential Communicator: You excel at stakeholder management, executive influence, and distilling intricate compliance regulations into clear, actionable clinical strategies.
Preferred
- Advanced degree (Master’s, PharmD, PhD, or JD) in a scientific, medical, or regulatory discipline.
- Direct prior experience supporting Early Clinical Development (Phase 0–IIa/b) and translational research quality assurance.
- Proven leadership experience managing or mentoring quality compliance professionals, working groups, or direct reports.
- Hands-on experience hosting and leading Health Authority inspections (e.g., FDA, EMA, PMDA) and authoring formal regulatory responses.
- Expertise in developing and scaling QMS architectures, quality metrics, and risk-based quality management (RBQM) platforms.
Location
- This role is based in South San Francisco and offers a hybrid schedule working 3 day per week on campus
- No relocation benefits are available for this posting
The expected salary range for this position based on the primary location of CA is $174,700 - $324,500 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
