Full-Time

Director of Clinical Quality

Posted on 11/25/2024

Revolution Medicines

Revolution Medicines

201-500 employees

Develops targeted therapies for RAS cancers

Biotechnology
Healthcare

Compensation Overview

$175k - $210kAnnually

Senior, Expert

San Carlos, CA, USA

Hybrid position requiring in-office attendance.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Google Cloud Platform
Requirements
  • A Bachelor of Science (B.S.) in a scientific or technical discipline is required.
  • Minimum of 12 years of pharmaceutical clinical quality assurance experience in support of clinical development and clinical operations.
  • Extensive knowledge of relevant ICH, FDA, 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 commercial).
  • Experience in hosting 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 company’s Quality Systems and their associated processes, policies, and procedures.
Responsibilities
  • Provide support and guidance for 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 that comply with applicable GCP standards and guidelines.
  • Support a risk-based audit and compliance strategy for multiple programs.
  • Support timely completion of comprehensive 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.
  • Implement GLP/GCP inspection readiness activities.
  • Interact with the FDA and other regulatory agencies, as needed.
  • 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), Investigator’s Brochure, and CSR.
  • Escalate identified issues to QA Management and other relevant leadership as needed and in a timely manner.
  • Partner with GLP team members on activities that may impact GCP studies/data.
  • Enable other assigned GCP or GXP tasks, as appropriate.
  • Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Revolution Medicines develops treatments specifically for cancers caused by RAS gene mutations, which are common in difficult-to-treat cancers like pancreatic, colorectal, and lung cancers. Their main product line includes RASON Inhibitors, which target and inhibit RAS proteins that contribute to cancer growth. The company uses a Tri Complex Inhibitor platform to create these specialized therapies. Unlike many competitors, Revolution Medicines focuses solely on RAS-driven cancers, allowing them to concentrate their research and development efforts in this niche area. Their goal is to transform cancer treatment by providing effective targeted therapies for patients suffering from these challenging conditions.

Company Stage

IPO

Total Funding

$219.8M

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

12%

1 year growth

36%

2 year growth

137%
Simplify Jobs

Simplify's Take

What believers are saying

  • Acquisition of EQRx adds over $1 billion in capital for research and development.
  • Increased interest in targeted therapies boosts investment and partnership opportunities.
  • Shift towards personalized medicine aligns with their focus on genetic mutations.

What critics are saying

  • Integration challenges with EQRx could disrupt operations and delay timelines.
  • EQRx's pricing model may conflict with Revolution Medicines' market strategies.
  • $600M public stock offering may dilute existing shareholder value.

What makes Revolution Medicines unique

  • Revolution Medicines uses a unique method to synthesize pharmaceutically optimized natural compounds.
  • Their Tri Complex Inhibitor platform targets RAS proteins driving cancer growth.
  • Exclusive licensing with the University of Illinois enhances their proprietary technology.

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