Director, Clinical Development

Revolution Medicines•Redwood City, CA

4h•Hybrid

About The Position

The 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. 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%.

Requirements

A PhD, PharmD or equivalent is required.
Minimum 8+ 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.

Nice To Haves

Oncology and/or late-stage experience is preferred.
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.

Responsibilities

Contribute to the scientific, clinical, and operational scope of assigned study protocols.
Work with the cross-functional teams for the design, execution, and monitoring of clinical studies
Oversee data review, interpretation, and communication to both internal and external stakeholders.
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.