Senior Clinical Trial Manager

Revolution Medicines; San Francisco (CA); On-site; USD 116,000 - 145,000; Full time

Job summary

Join a pioneering company dedicated to precision oncology, where you'll play a crucial role as a Senior Clinical Trial Manager. This dynamic position offers you the chance to lead clinical operations for groundbreaking therapies targeting RAS-addicted cancers. You'll work closely with cross-functional teams, ensuring compliance with FDA regulations while managing clinical trials from inception to completion. If you thrive in a fast-paced, collaborative environment and are passionate about making a difference in cancer treatment, this is your opportunity to contribute to innovative solutions that impact patients' lives.

Benefits

Competitive cash compensation

Robust equity awards

Strong benefits

Learning and development opportunities

Qualifications

• 7+ years of clinical operations experience in pharma or biotech, mainly in oncology.
• Strong knowledge of FDA regulations and GCP for clinical trials.

Responsibilities

• Manage clinical studies to ensure compliance with SOPs and FDA regulations.
• Oversee CRO activities and ensure timely completion of clinical trials.
• Collaborate with internal teams to achieve clinical study goals.

Skills

Clinical Operations

Vendor Management

Communication Skills

Regulatory Knowledge (FDA, GCP, ICH)

Team Collaboration

Multi-tasking

Clinical Trial Management

Education

BS or MS degree

Tools

Electronic Data Capture (EDC)

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 company’s 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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

This is a unique opportunity for an experienced Clinical Operations Professional who has technical expertise in managing Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) regulatory requirements. Oncology experience is preferred. As the Senior Clinical Trial Manager of Clinical Operations, initially reporting to the Director, Clinical Operations, you will be responsible for Contract Research Organization (CRO) oversight and execution of Revolution Medicines clinical studies.

Key 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.

Required Experience, Skills, and Education:

• BS or MS degree with a minimum of 7 years clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in oncology drug development.

• 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%).

Preferred Skills:

• Experience in working with cooperative group studies and investigator sponsored trials, preferred.

• Experience of Global clinical trial operations outside the USA.

• Excellent knowledge of the APAC region.

The base salary range for this full-time position is $116,000 to $145,000 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.