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Full-Time

Clinical Trial Manager

Updated on 9/10/2024

Revolution Medicines

Revolution Medicines

201-500 employees

Develops targeted therapies for RAS cancers

Hardware
Biotechnology
Healthcare

Compensation Overview

$105k - $135kAnnually

+ Equity Awards + Benefits + Learning and Development Opportunities

Senior

San Carlos, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Quality Assurance (QA)
Requirements
  • BS or MS degree with a minimum 5 years clinical operations experience in the pharmaceutical or biotech industry.
  • Hands-on experience of running early-stage clinical trials within an industry environment.
  • Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
  • Experience in selection of CROs/ vendors and management of external resources.
  • A demonstrable record of strong vendor management and teamwork.
  • Direct experience of managing clinical CROs.
  • Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.
  • Ability to travel (~25%).
Responsibilities
  • Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives.
  • Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines.
  • Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) provider, and independent contractors) to execute clinical trials.
  • Reviewing and contributing to the development of study-specific documentation including clinical trial protocols, case report forms, study guides/manuals, informed consent forms and clinical database.
  • Reviewing monitoring reports and other study documentation as required.
  • Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).
  • Participation in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
  • Following up on assigned team action items and identification, escalation, and resolution of issues as needed.
  • Collaboration with contracts specialist to review and negotiate Clinical Trial Agreements and site specific study budgets.
  • Assessment of adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP.
  • Development of clinical study monitoring priorities and Monitoring Plan in conjunction with CRO.
  • Conduct site visits (e.g., training visits, site initiation visits, monitoring visits), as required.
  • Managing investigational product accountability and reconciliation process.
  • Assistance with the preparation of safety, interim and final clinical study reports, and resolution of data discrepancies.
  • Providing clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.
  • Preparation and tracking of study participant enrollment projections vs. actuals and study budgets.
  • Serving as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.

Revolution Medicines develops targeted treatments for cancers caused by RAS gene mutations, which are common in difficult-to-treat cancers like pancreatic, colorectal, and lung cancers. Their main products are RASON Inhibitors, designed to inhibit the activity of RAS proteins that promote cancer growth. The company uses a Tri Complex Inhibitor platform to create these specialized therapies. Unlike many competitors, Revolution Medicines focuses specifically on RAS-driven cancers, allowing them to carve out a niche in the oncology market. Their goal is to transform cancer treatment by providing effective therapies for patients suffering from these challenging conditions.

Company Stage

IPO

Total Funding

$1.3B

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

12%

1 year growth

40%

2 year growth

111%
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Simplify's Take

What believers are saying

  • The acquisition of EQRx is expected to add over $1 billion in net cash, significantly bolstering Revolution Medicines' financial position.
  • Successful public offerings and underwriters' full exercise of options have brought substantial capital, indicating strong investor confidence.
  • The company's innovative RASON Inhibitors and Tri Complex Inhibitor platform have the potential to revolutionize treatment for RAS-driven cancers, offering significant clinical impact.

What critics are saying

  • The highly specialized focus on RAS-driven cancers may limit market size and revenue potential compared to broader oncology companies.
  • Integration challenges from the acquisition of EQRx could divert focus and resources, potentially impacting ongoing projects.

What makes Revolution Medicines unique

  • Revolution Medicines focuses exclusively on RAS-driven cancers, a niche but critical area in oncology, unlike broader-spectrum oncology companies.
  • Their Tri Complex Inhibitor platform allows for highly specialized treatments, setting them apart from competitors with more generalized approaches.
  • The company's revenue model, which includes licensing, co-development partnerships, and direct sales, provides multiple revenue streams, enhancing financial stability.