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 a Clinical or Outsourcing Professional who has expertise in managing Clinical Trial Contracts for 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 Clinical Contract Coordinator/Clinical Contract Manager, initially reporting to the Associate Director/Director Clinical Operations, you will be responsible for Contract Research Organization (CRO), Vendor and Site contract oversight in support of execution of Revolution Medicines clinical studies.

Specifically, you will be responsible for:

Manage activities related to clinical outsourcing of global CROs/vendors (e.g. Global CRO, core labs, Electronic Data Capture (EDC) providers, Phase 1 unit CRO, and independent contractors), and clinical sites, including negotiation of contracts and budgets such as MSAs, Work Orders, Change Orders and CTAs. 

• Manage a high volume of contract agreements from start to finish to support clinical operational needs. Support Clinical Operations contract and budget activities related to the execution of assigned clinical programs based upon department and corporate goals and objectives.

• Management of clinical study and vendor budgets to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonisation (ICH)/ GCP guidelines. Manage and track CRO/vendor budget, including direct and pass through costs, out of scope, and investigator grants.

• As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and external customers, possesses detailed and in-depth knowledge of the contracting process and budget development.

• Communicates confidently and competently to liaise with others through excellent negotiation skills.

• Has excellent communication, project management & critical thinking skills; and is comfortable interacting with internal and external team members, such as, clinical operations, finance, legal, accounting, project operations, project management and CRO/vendor and clinical site team members.

• Participation in team meetings and collaborating with other functional groups within the company to achieve clinical study goals.

• Complete tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently, to support corporate priorities and timelines.

• Gather data required for vendor bidding and proposal development (e.g., RFI/RFP creation and analysis).

• Provide administrative support throughout the life cycle of vendor selection process.

• Assist Clinical Operations Lead with vendor assessments including, but not limited to, Vendor Qualifications, IT Security Assessments. Assist with clinical study/program budget analysis, review, and projections.

• Follow up on assigned action items and identification, escalation, and resolution of issues as needed.

Required Experience, Skills, and Education:

• BS degree with a minimum of 2-3 years clinical contracts or clinical operations experience in the pharmaceutical or biotech industry, preferably in early phase oncology drug development.

• Knowledge of the drug development process with a passion for drug development in a biotech setting.

• Experience with clinical trial (CRO/vendor and site) contract negotiation

• Experience with contract budget management and tracking.

• Experience with clinical trial budget management with global trials (e.g., including sites outside the USA) is desirable, but not essential.

• Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.

• Experience in selection of CROs/ vendors and budget tracking for external resources.

• A demonstrable record of strong vendor management and teamwork.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Demonstrable knowledge of current contracting as well as legal and regulatory environment as it related to the pharmaceutical/biotech industry.

• Excellent written and verbal communication skills.

• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.

• Ability to work independently while managing multiple priorities.

• Some knowledge of Data Privacy Regulations/Laws (e.g. GDPR, HIPAA, PIPEDA).

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

The expected salary range for this role is $120,000 to $158,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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 our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.