Associate Director, Clinical Operations, Compliance and Training
Revolution MedicinesRedwood City, CA, US7 days ago
Job type
- Full-time
Job descriptionBachelor's degree in biological sciences or health-related field required. 10+ years direct Clinical Operations and / or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement. Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP. Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements. Experience with development and monitoring of oversight activities. Knowledge and / or familiarity with Ex-US region(s) e.g. EMA clinical trial operations. Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions. Strong analytical, negotiation, and persuasion skills. Ability to deal with time demands, incomplete information, or unexpected events. Outstanding organizational skills with the ability to multi-task and prioritize. Excellent interpersonal, verbal, and written communication skills. Decision-making skills. Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities. Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and / or Smartsheet a plus. Travel may be required (~25%). Line Management experience Oncology experience, early and / or late stage, strongly preferred. RN or Masters degree in biological sciences or health-related field preferred. Strong working knowledge of ex-US regulations and requirements.
Compliance Professional Opportunity
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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity :
- This is a unique opportunity for a Compliance Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting.
- As an Associate Director, you will be responsible for leading or supporting the development and implementation of GCP systems and inspection readiness.
- Lead or support the development and continuous improvement of Clinical Policies / SOPs / WIs / Templates / etc. using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.
- SME for Clinical Operations GCP guidance, best industry practices, SOPs and audit responses.
- Contribute to the development and management of business and compliance metrics to assess and continuously improve RevMed oversight and inspection readiness throughout the clinical trial lifecycle.
- Support Clinical Operations Inspection Readiness activities with clinical study teams; key participation in Mock / Regulatory Authority inspections.
- Contribute to the development and execution of Clinical Operations training programs to deliver RevMed standards, GCP, and regulatory requirements.
- Partner cross-functionally and with QA on quality initiatives and continuous improvement of GCP systems.
- Line management responsibilities including hiring, performance management, career development, and mentorship.
- Participate in other Clinical Operations Activities per the business need.
Required Skills, Experience and Education :
Preferred Skills :
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Associate Director Clinical • Redwood City, CA, US