The Director of Clinical and Pharmacovigilance Quality is responsible for participant safety, data integrity, and global regulatory compliance across the Company's clinical development and pharmacovigilance activities. Operating in a lean, fast-paced biotech environment with multiple concurrent Phase II and Phase III studies across global geographies and a heavily outsourced CRO and vendor model, this leadership role establishes and manages a risk-based quality strategy; oversees GCP and GVP compliance across investigator sites, CROs, and safety vendors; leads inspection and marketing-application readiness; drives quality governance, metrics, and continuous improvement; and serves as a hands-on strategic quality partner to Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory, and Data Management.
Responsibilities
- Audit and Oversight
- Establish and manage a risk-based audit program across clinical development and pharmacovigilance activities.
- Lead the planning, scheduling, execution, and follow-up of investigator sites, CRO, clinical vendors, safety vendors, and internal audits across U.S. and ex-U.S. geographies, including risk-based, routine, and for-cause audits.
- Oversee audits and assessments of clinical and pharmacovigilance documentation, systems, and processes, including Trial Master Files, electronic systems (EDC, eTMF, safety database), safety processes, and related records, with particular focus on pivotal-trial inspection readiness.
- Quality Management System
- Develop, maintain, and continuously improve fit-for-purpose quality policies, standard operating procedures, and associated documents supporting clinical and pharmacovigilance operations, aligned with ICH E6(R3), ICH E8(R1), and applicable GVP guidance.
- Oversee quality events, deviations, CAPAs, change controls, and training processes across clinical and pharmacovigilance functions.
- Support quality governance processes through the development, monitoring, and reporting of quality metrics, trends, and key performance indicators for clinical and pharmacovigilance functions.
- Inspection Readiness and Compliance
- Lead company-wide inspection readiness activities for GCP and pharmacovigilance inspections by global Health Authorities (e.g. FDA, EMA, MHRA etc.), including sponsor pre-approval and pre-license inspections supporting marketing applications (NDA/MAA).
- Prepare and support internal teams, sponsors, and/or clinical sites during inspections and regulatory interactions.
- Coordinate, author, and oversee responses, corrective actions, and remediation plans for inspection and audit findings.
- Serve as a primary quality and compliance resource for clinical and pharmacovigilance functional areas, monitoring trends and applying insights to strengthen oversight.
- Regulatory and Operational Support
- Provide quality oversight and review of regulatory submissions (including IND/CTA, IMPD/CTIS, annual reports, DSURs, SUSARs, and marketing applications) and operational processes, as applicable, to support compliant clinical development and pharmacovigilance activities.
Requirements
- Bachelor's degree in a scientific, medical, or related field required; an advanced degree or quality certification is preferred.
- Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, including at least 5 years of direct quality experience supporting clinical development and/or pharmacovigilance. Small or mid-size biotech experience and direct support of Phase 2/3 pivotal programs strongly preferred.
- Strong working knowledge of ICH-GCP (E6(R2/R3)), ICH E8(R1), EU GVP modules, FDA 21 CFR Parts 11, 50, 54, 56, 312, and 314, and applicable global clinical trial and safety regulations issued by FDA, EMA, MHRA, PMDA, and Health Canada.
- Demonstrated experience supporting audits, inspections, and quality systems across clinical and pharmacovigilance functions.
- Experience providing quality oversight of key clinical and pharmacovigilance processes, including investigator site, CRO, and vendor oversight under sponsor accountability; adverse event case processing; aggregate reporting (DSUR, SUSAR, etc.); signal management; and inspection readiness.
- Working knowledge of quality system requirements, including deviations, Quality Investigations, CAPAs, change controls, training, clinical complaints, and procedural documentation.
- Experience developing, monitoring, and communicating quality metrics, dashboards, and governance reports to support Quality Councils and continuous improvement activities.
- Experience supporting or auditing documentation and systems relevant to clinical development and pharmacovigilance, including Trial Master Files, safety records, and related procedural documents.
- Willingness to travel domestically and internationally up to 30% as needed for audits, clinical site visits, conferences, inspections, and other business support.
The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $200K - $215K
