Full-Time

Associate Director

Clinical Quality

Confirmed live in the last 24 hours

Revolution Medicines

Revolution Medicines

501-1,000 employees

Develops targeted therapies for RAS cancers

Biotechnology
Healthcare

Compensation Overview

$180k - $225kAnnually

Senior, Expert

San Carlos, CA, USA

Hybrid position requiring in-office presence.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Word/Pages/Docs
Risk Management
Google Cloud Platform
Excel/Numbers/Sheets

You match the following Revolution Medicines's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Bachelor’s degree in scientific or technical discipline.
  • A minimum of 8 years of experience in GCP Quality in the pharmaceutical or biotechnology industry.
  • 8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.
  • Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations.
  • Effective communication (verbal and written).
  • Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.
  • Ability to create innovative solutions to problems, while integrating stakeholder input and feedback.
  • Ability to critically evaluate and troubleshoot complex problems with diligence.
  • Ability to manage multiple priorities and aggressive timelines.
  • Highly responsible, self-motivated professional with enthusiasm and passion for the work.
  • Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).
Responsibilities
  • Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines.
  • Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
  • Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
  • Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
  • Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.
  • Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.
  • Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).
  • Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management.
  • Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner.
  • Enable other assigned GCP or GXP related tasks, as appropriate.
  • Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners.
  • Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.
Desired Qualifications
  • Good knowledge of Computer System Validation.

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 the 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

-2%

1 year growth

-3%

2 year growth

7%
Simplify Jobs

Simplify's Take

What believers are saying

  • Acquisition of EQRx adds over $1 billion in capital for R&D.
  • FDA fast-tracking supports their RAS-targeted therapy pipeline.
  • Growing interest in targeted cancer therapies boosts investment opportunities.

What critics are saying

  • EQRx acquisition may pose integration challenges and cultural clashes.
  • $600M public stock offering could lead to shareholder dilution.
  • Focus on RAS-addicted cancers limits market scope and increases competition risk.

What makes Revolution Medicines unique

  • Revolution Medicines reconfigures natural substances into best-in-class cancer therapies.
  • Their Tri Complex Inhibitor platform targets RAS proteins driving cancer growth.
  • Exclusive license with University of Illinois enhances their unique synthesis technology.

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Benefits

Company Equity