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.