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Redwood City, California, United States
Hybrid
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Senior Director of Clinical Data Management (CDS OpsEx) provides high-level leadership for Data Management and functions within clinical development including Information Operations, Data Products, and Clinical Data systems, focusing on strategic development, operational execution and excellence, and regulatory compliance to ensure data integrity for clinical trials. Key responsibilities include leading and managing data management and cross-functional teams, establishing and enforcing data management policies and procedures, overseeing departmental budgets, collaborating with cross-functional stakeholders and vendors, and ensuring data management processes, systems and systems integrations meet regulatory standards. This role requires extensive experience in the clinical data management setting, strong leadership and communication skills, expertise in clinical trial methodologies and systems, and a deep understanding of regulatory requirements including submissions and data management systems.
Required Skills, Experience and Education:
MS, BS/BA degree, or other suitable qualification with relevance to the field.
17 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.
Help define and implement the overall vision, strategy, and goals for the clinical data management department, including developing and enforcing departmental SOPs, with a focus on data standards, systems, system integration and operational excellence and efficiency.
Extensive experience in clinical data management processes and systems, with proven leadership experience in oncology therapeutic area.
Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.
Proven track record of developing and implementing clinical data standards and governance, with a focus on Oncology data standards.
Automation and digital transformation initiatives to improve data quality and efficiency (e.g., IXRS, AI/ML tools, RBQM platforms, RSG implementation/E2B, in-house coding implementation, in-house CTMS development support, other clinical development systems implementation and integrations).
Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.
Experience focused on people, process, technology, and cost optimization, with a strong emphasis on data standards, process simplification, AI-driven automation, and building high-performing teams while reducing costs.
Demonstrated ability to lead, motivate, and develop teams.
Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.
Develop and monitor KPIs for data quality and operational performance.
Manage relationships with Contract Research Organizations (CROs) and other data management vendor partners, ensuring they meet quality and performance standards.
Forecast, manage, and provide oversight for departmental budgets, including internal and external expenditures.
Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.
Experience with global trials and regulatory submissions (FDA, EMA).
In-depth understanding of industry standards related to clinical data management (e.g., medical dictionary coding).
Guide data management activities for regulatory submissions and represent the department during regulatory inspections and internal audits.
Serve as a key liaison and collaborate effectively with cross-functional teams (e.g., Clinical, Quality, Regulatory) and key external stakeholders.
Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.
Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.
Preferred Skills:
A degree in life science, health informatics, or a related field.
Exposure to real-world data (RWD) and decentralized trial models.
Experience building psychological safety across the Clinical Data Management team, stakeholders and partners to foster collaboration, encourage open communication, and improve team performance.
Experience developing a low-cost FSP model.
#LI-DN1 #LI-Hybrid
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range 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.
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Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
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