Executive Director and Head of Clinical Data Management

Redwood City - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 Executive Director and Head 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.
Bachelors Degree with 15 years of relevant experience required or Masters Degree with 13 years of relevant experience preferred.

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-GL1

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.

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 ourCCPA additional information please contact .

Base Pay Salary Range

$256000$320000 USD

Required Experience:

Director