Remote Opportunity

Senior Director, Clinical Operations, Japan

Join Revolution Medicines as a staff professional working remotely from Japan. Explore the role, benefits, and apply in one place.

Full Time
3 weeks ago

Revolution Medicines is hiring a remote staff full-time Operations role, Senior Director, Clinical Operations, Japan, for candidates in Japan. Skills include Clinical Operations, Project Management, ICH Guidelines, GCP.

Japan
Operations
Staff
Clinical Operations
Project Management
ICH Guidelines
+5 more

Job Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. 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 the right individual who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in organizing and running clinical trials. As the Senior Director of Clinical Operations, you will be responsible for the operational design and structure of, and accountable for the execution of, Revolution Medicines early-stage clinical studies in Japan. Specifically, you will be responsible for: The development, management, and execution of the Clinical Development Plan (CDP) for clinical programs which includes clinical trial timeline estimates, budgets, and resource requirements in Japan. Oversight over the execution of clinical trials, including CRO selection and site selection in Japan. Lead the strategic planning, optimization, and deployment of Clinical Operations resources across Japan, ensuring effective alignment with both project and non-project. Line management responsibilities include hiring, performance management, career development and mentorship. Lead team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, DMPK, Regulatory, QA, Finance, Legal, etc.) as an ad-hoc member to achieve clinical study goals regulations and International Council for Harmonization (ICH)/ GCP guideline. Required Skills,

Experience and Education: BS/MS Degree in a scientific discipline with a minimum of 12 years of clinical operations experience in the pharmaceutical or biotech industry. Minimum of 7 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. A demonstrable record of strong leadership and teamwork. 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, pharmacovigilance and other related functions to clinical trial conduct. Strong working knowledge of PMDA/MHLW 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. 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 both in English and Japanese. Ability to act as an excellent ambassador for Revolution Medicines in interactions with key opinion leaders, scientific advisors, corporate partners and, where necessary, investors. Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.

Preferred Skills: Experience in oncology clinical trials. 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 our CCPA Notice and Privacy Policy. For additional information, please contact [email protected]. We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.

Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.

If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.

Skills

Clinical Operations
Project Management
ICH Guidelines
GCP
Clinical Oncology Drug Development
Line Management
CRO Selection
PMDA/MHLW Regulations

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Posted 3 weeks ago

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