Associate Director, Clinical Operations, Compliance and Training at Revolution Medicines

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Apr, 26

Salary

233000.0

Posted On

22 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Compliance, Training, GCP, SOPs, Regulatory Requirements, FDA Regulations, ICH Guidelines, Analytical Skills, Negotiation Skills, Interpersonal Skills, Communication Skills, Decision-Making Skills, Organizational Skills, Performance Management, Oncology

Industry

Hospitals and Health Care

Description

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: As an Associate Director, you will be responsible for the following: Lead and/or support development and implementation of GCP systems and inspection readiness. Lead and/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, continuous improvement of GCP systems, and internal audits. 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: Bachelor’s degree in biological sciences or health-related field required. 10+ years direct Clinical Compliance, and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations 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, MHRA, PDMA. Ability to perform complex assessments & investigations, 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%). Preferred Skills: Line Management experience. Oncology experience, early and/or late stage, strongly preferred. RN or Master’s degree in biological sciences or health-related field preferred. Strong working knowledge of ex-US regulations and requirements. #LI-Hybrid #LI-DN1 The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. 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 privacy@revmed.com. Base Pay Salary Range $186,000—$233,000 USD

Responsibilities

The Associate Director will lead the development and implementation of GCP systems and support inspection readiness. They will also contribute to the development of clinical policies and training programs while managing compliance metrics.