Associate Director, Clinical Operations Compliance & Training

Job Title: Associate Director, Clinical Operations Compliance & Training

Location: Bay Area, California, United States

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, along with RAS Companion Inhibitors for use in combination treatment strategies, currently in clinical development.

The Opportunity:

As an Associate Director, you will be responsible for the following:

• Lead and/or support development and implementation of Google Cloud Platform 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 (Google Cloud Platform) and regulatory requirements.
• SME for Clinical Operations Google Cloud Platform guidance, best industry practices, SOPs, and audit responses.
• Contribute to the development and management of business and compliance metrics to assess and continuously improve 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 company standards, Google Cloud Platform, and regulatory requirements.
• Partner cross-functionally and with QA on quality initiatives, continuous improvement of Google Cloud Platform 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 experience may also meet the requirement.
• Strong working knowledge of FDA Regulations, ICH Guidelines, and Google Cloud Platform.
• Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with Google Cloud Platform 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 environment and able to adjust workload based upon changing priorities.
• 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.