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Associate Director, Clinical Development

Associate Director, Clinical Development

Revolution MedicinesRedwood City, CA, US
30+ days ago
Job type
  • Full-time
Job description

Associate Director, Clinical Development

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

The Opportunity :

The Associate Director, Clinical Development will contribute to the scientific, clinical, and operational scope of assigned study protocols. This role will work with the cross-functional teams for the design, execution, and monitoring of clinical studies, as well as oversee data review, interpretation, and communication to both internal and external stakeholders. Oncology and / or late-stage experience is preferred.

Responsibilities :

  • Develop and execute clinical development strategies and the Clinical Development Plan (CDP) with a focus on early-phase development.
  • Lead cross-functional teams with oversight from senior team members to conduct clinical studies, including study start up, execution and close out activities, data review / analysis, and preparation of study reports.
  • Oversee the development of program-level documents, including but not limited to clinical protocols, investigator's brochure, clinical study reports, abstracts and manuscripts, presentations, and various other internal and external documents and communications as needed.
  • Conduct ongoing data reviews; prepare and present summaries to internal and external stakeholders.
  • Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and / or individual subject safety.
  • Interact with internal and external stakeholders (investigators, study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalation.
  • Conduct literature reviews as needed.
  • Travel : Up to 20%.

Required Skills, Experience and Education :

  • BS / BA and master's degree in a scientific discipline, or other relevant advanced degree in a health science field.
  • Minimum 7 years of experience in the pharmaceutical or biotechnology industry as a clinical scientist or related role.
  • Proven leadership in a collaborative team setting and driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  • Detail-oriented with ability prioritize tasks and function independently as appropriate.
  • Strong organizational skills and an ability to interpret, discuss, and report trial / program level data effectively and identify trends.
  • Proficient with software tools (Microsoft Office), Electronic Data Capture, and other custom web-based software.
  • Excellent written and verbal communication skills.
  • Preferred Skills :

  • Strong experience with clinical data review and data quality assurance.
  • Knowledge and experience with clinical trial management and oversight.
  • Understanding and experience in clinical trial protocol and regulatory document authoring.
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    Associate Director Clinical • Redwood City, CA, US

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