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 quality professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Sr. Clinical Program Manager Clinical Operations, Clinical Operations Excellence, you will be responsible for development and implementation of processes to contribute to Clinical study quality and inspection readiness.

  • Using knowledge of and experience with successful clinical study management activities, and strong knowledge of Clinical Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines, you will be responsible to develop clinical SOPs, develop and manage clinical study quality processes and assess study team compliance.

  • Contribute to development and management of processes and systems which will facilitate clinical trials to maintain an inspection readiness state throughout the lifecycle of the trial.

  • Partner with Clinical Operations and cross-functional team members to improve processes that will impact clinical trial management, quality and efficiency.

  • Responsibilities may include development and management of processes for study monitoring oversight activities and clinical study vendor SOP review.

  • Responsibilities may include development and management of process for posting clinical trial registration and results information on clinical trial registries.

  • May lead interdepartmental strategic business initiatives as well as spearhead SOP development and training.

  • Assists in the hiring, development and retention of top talent within the team. Coaches direct report(s) on their performance, development, and career interests.

  • Partner within Clinical Operations and with QA on remediation of quality issues and implementation of continuous improvement initiatives.

  • Participate in other Clinical Operations Activities as appropriate.

Required Skills, Experience and Education:

  • RN or Bachelor’s degree in biological sciences or health-related field required.

  • 10+ years direct Clinical Operations or a combination of Clinical Operations and Clinical Quality Assurance experience in the pharmaceutical or biotech industry, Relevant indirect experiences may also meet the requirement.

  • Some experience managing or overseeing the work of consultant.

  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

  • Demonstrated experience successfully developing and authoring Clinical Operations and cross-functional SOPs and Clinical study process templates in support of clinical study management, oversight and inspection readiness.

  • Experience with development and implementation of study vendor and monitoring oversight activities.

  • Minimum of 6 years of cross-functional study management or related leadership experience in life sciences.

  • Experience in selection and management of external resources (e.g., CROs, vendors, contractors).

  • Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

  • Demonstrated comprehension of clinical study protocols and understanding of relevant regulations enabling management of the clinical trial registry posting process.

  • Be solution-oriented by anticipating obstacles and difficulties and proactively providing risk assessment and mitigation strategies to achieve project goals.

  • Ability to deal with time demands, incomplete information, or unexpected events.

  • Outstanding organizational skills with the ability to multi-task and prioritize.

  • Excellent interpersonal, verbal and written communication skills.

  • High sense of priority and commitment to excellence in the successful execution of deliverables.

  • Ability to review and assess vendor SOPs for alignment with and/or gaps compared to sponsor SOPs and study documents.

  • Ability to communicate with Clinical Operations and cross-functional team members across study teams to assure compliance with company SOPs and processes, and FDA Regulations, ICH Guidelines, and GCP.

  • Ability to contribute with a mind on quality, diligence, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute goals as a member of the Clinical Operations Excellence team.

  • Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

  • Travel may be required (~25%).

Preferred Skills:

  • Familiarity working with systems/portals (e.g., eTMF, EDC, IRT, CTMS).

  • Experience with e-system implementation and management.

  • Oncology experience, early and/or late stage, strongly preferred.

  • Experience in start-up, management, and close-out of clinical trials, including authoring clinical study and regulatory documentation.

  • Experience conducting on-site monitoring.

  • Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

  • Familiarity and experience with managing risk-based monitoring.

  • Experience working within Veeva Quality Documents and Quality Management Systems or similar system(s).

  • Experience drafting, submitting and updating clinical trial registration and results information on ClinicalTrials.gov.

The base salary range for this full-time position is $150,000 to $198,000 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.

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

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