Director, Clinical Quality
Director, Clinical Quality
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$ 204000 - 255000
1 Vacancy
Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Opportunity:
The Director of Clinical Quality will play a key role in Quality Assurance and have direct responsibility for the clinical quality workstreams and study teams. This role is responsible for providing quality and compliance oversight for RevMed-sponsored clinical trials with respect to RevMeds Standard Operating Procedures applicable regulatory requirements (FDA EU ICH & country-specific) and current industry standards and practices. This role will support daily compliance operational activities evaluate risk and resolve quality events for early phase through late-phase clinical programs. This role will also be responsible for managing multiple studies including GLP activities that impact clinical studies/data. This role will report to the Head of Clinical Quality.
Act as the study lead for Phase 3 program(s) provide support and guidance to the Clinical Development and Clinical Operations functions including but not limited to the following functional areas: Global Patient Safety Translational Medicine and Data Management.
Lead the development and maintenance of applicable GCP Quality Systems procedures that comply with applicable GCP standards and guidelines.
Work with Quality Leadership to develop a risk-based GCP audit program and compliance strategy for RevMed clinical study programs.
Manage external GCP auditors and support timely review of audit reports and communicate findings to auditees cross-functional representatives and management. Ensure the corrective and preventative action (CAPA) plans adequately address findings and root causes including effectiveness checks where appropriate.
Support global regulatory due diligence and partner inspections at Sponsor including preparing the site training the staff on regulatory inspection management best practices.
Represent Clinical Quality during global regulatory inspections at RevMed including supporting regulatory inspections at clinical sites for RevMed clinical studies.
Oversee study documentation including TMF for accuracy and inspection readiness.
Perform quality reviews of Clinical Study Documents with a focus on compliance / regulatory requirements and risk assessment. The study documents include but are not limited to: Study Protocols ICFs Annual Reports (e.g. DSUR) other subject-facing documents (brochures recruitment materials) Investigators Brochure and CSR.
Escalate quality events IPDs potential serious breaches to Quality Management and other relevant leadership as needed and in a timely manner including initiating CAPAs and CIs to address major findings and gaps.
Compile track GCP quality metrics (KPI) and vendor performance on all RevMed initiated clinical studies and report to quality management on a quarterly basis.
Partner with GLP team members on activities that may impact GCP studies/data.
Perform other assigned GCP or GXP tasks as appropriate.
Manage a team of clinical QA professionals and contractors and mentor QA staff.
Build positive professional relationships and trust to support learning respect open communication collaboration and teamwork.
Required Skills Experience and Education:
A Bachelor of Science (B.S.) in a scientific or technical discipline is required.
Minimum of 15 years of pharmaceutical clinical quality assurance experience providing quality oversight and supporting multiple late-stage clinical studies (Phase II to III).
Extensive knowledge of relevant ICH E6 FDA EMA HC and PMDA and other regulatory requirements and guidance documents with practical application and execution of GLP and GCP requirements.
Experience with the application of phase-appropriate quality systems across the product development lifecycle (Phase 1 through Phase III).
Experience in regulatory inspections and in dealing with regulatory agencies throughout the drug product approval process.
Professional and respectful communication skills (verbal / written).
Ability to effectively communicate with business partners and third-party clinical vendors and their quality assurance representatives to ensure RevMed requirements are met and to resolve issues/discrepancies.
Oral and written presentation skills are needed to address colleagues at all levels of the organization e.g. internal training presentations presentations of CRO performance metrics and coordination of inspection readiness activities.
Ability to work on multiple projects manage competing priorities and collaborate cross-functionally in a dynamic fast-paced environment.
Ability to contribute to the development performance monitoring and continuous improvement initiatives related to the companys Quality Systems and their associated processes policies and procedures.
Preferred Skills:
Experience managing oncology clinical studies and 4 years of GLP quality assurance experience is preferred.
An advanced degree is a plus.
The base salary range for this full-time position is $204000 to $255000 for candidates working onsite at our headquarters in Redwood City CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role level and location. Individual pay is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed which includes competitive cash compensation robust equity awards strong benefits and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital status medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect process and use any personal data that you provide to us in accordance with ourCCPA additional information please contact
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Required Experience:
Director
Employment Type
Full Time
