Senior Director, Clinical Data Management

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Senior Director of Clinical Data Management provides high-level leadership for data management functions within clinical research focusing on strategic development operational execution and regulatory compliance to ensure data integrity for clinical trials. Key responsibilities include leading and managing data management teams establishing and enforcing data management policies and procedures overseeing departmental budgets collaborating with cross-functional teams and vendors and ensuring data management processes meet regulatory standards. This role requires extensive experience in clinical data management strong leadership and communication skills expertise in clinical trial methodologies and a deep understanding of regulatory requirements including submissions and data management systems.

Required Skills Experience and Education:

• Define and implement the overall vision strategy and goals for the clinical data management department including developing and enforcing departmental SOPs.

• 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.

• Extensive experience in clinical data management 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.

• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.

• Demonstrated ability to lead motivate and develop teams.

• 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.

• 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.

Preferred Skills:

• A degree in life science health informatics or a related field.

• Exposure to real-world data (RWD) and decentralized trial models.

• Automation and digital transformation initiatives to improve data quality and efficiency (e.g. IXRS AI/ML tools RBQM platforms). #LI-Hybrid #LI-DN1