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Associate Director, Clinical Operations

Location: Redwood City
Posted on: January 8, 2022

Job Description:

Associate Director, Clinical Operations at Revolution Medicines Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value 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: This is a unique opportunity for an experienced Clinical Operations Professional who has technical expertise in managing Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) regulatory requirements. Oncology experience is preferred. As the Associate Director, reporting to the Director/Senior Director of Clinical Operations, you will be responsible for Contract Research Organization (CRO) oversight and execution of Revolution Medicines clinical studies. Specifically, you will be responsible for: Clinical operations functional activities related to the execution of assigned clinical programs based upon department and corporate goals and objectives. Contributing to the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs which includes timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct. Responsible for successful planning and deployment of Clinical Operations staff (potentially including clinical program managers/CTMs/CTAs) for project and non-project related tasks. Line management responsibilities include hiring, performance management, career development and mentorship. Oversight of assigned global clinical studies providing direction and oversight to Clinical Program Managers, CTMs/CTAs, as applicable, and CRO Study Teams. May be the lead for Study Execution Team to ensure protocol and regulatory compliance. Oversight of timelines, budgets, resources, CROs, and key deliverables to ensure studies are completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations, ICH/GCP guidelines. Participating in team meetings and collaborating with other functional groups within the company (e.g., Clinical Development, DMPK, Quantitative Science, Regulatory, CMC, QA, Finance, Legal, etc.) to achieve clinical study goals, in compliance with regulations and International Council for Harmonization (ICH)/ GCP guideline Providing technical expertise for the development of clinical documents including clinical trial protocols, study guides/manuals, investigational brochures, informed consent forms, etc. Developing and maintaining effective working relationships with internal team and external partners. Providing positive and professional leadership as the Clinical Operations representative for RevMed. -Required Experience, Skills, and Education: BS/MS Degree in a scientific discipline with a minimum of 10 years of clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in oncology drug development. Minimum of 4 years project and line management experience. Extensive experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources and budgets. Experience in working with cooperative group studies and investigator sponsored trials, preferred. Extensive experience in selection of CROs/ vendors and management of external resources. Must have a working knowledge of data management, data review and analysis, and drug safety and Pharmacovigilance. Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials. Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment. Excellent written and verbal communication skills. Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important. 29 Newbury Street
3rd Floor
Boston, MA 02116
P (617) 585-2000

Keywords: THIRD ROCK VENTURES, LLC, Redwood City , Associate Director, Clinical Operations, Executive , Redwood City, California

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