Senior Director, Clinical Operations, Japan

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.

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