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Associate Director, Clinical Operations

$186k - $233k
Full-time

Revolution Medicines

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 a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials. Responsibilities: * Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines. * Global experience in end-to-end execution of different phases of clinical trials. * Accountable for study delivery goals. Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets. * Guide assessment, selection, engagement, management, and oversight of appropriate vendors. * Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate. * Lead risk management and quality efforts to ensure study compliance and continual inspection readiness. Lead/contribute to ways of working and process improvement initiatives. * Provide proactive and consistent oversight of CRO and vendor performance Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives. * Contributions to the strategy and execution of the Clinical Development Plan (CDP) for assigned clinical programs which include timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct. * Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks. * Lead line management responsibilities that include hiring, performance management, career development, and mentorship. * Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and KPIs. * Lead cross functional team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals. * Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial. * Oversee the improvement of processes that will impact clinical trial management and deliverables including contingency plans by maintaining a highly effective Clinical Operations team and building strong relationships with functional leaders. Required Skills, Experience and Education: * RN or Bachelor’s or Master’s degree in biological sciences or health-related field required. * 11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.

  • Minimum of 5 years of project and first-line management experience.
  • Experience in oncology.
  • Experience in leading and managing global phase 1-3 clinical trials within
designated timelines, resources, and budgets.
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
  • Experience with vendor management and CRO oversight.
  • Ability to perform complex analysis, draw relevant conclusions, and implement
appropriate solutions. * Ability to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.
  • 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%).
  • Demonstrated experience leading in the matrix environment to deliver
projects, develop clinical plans and manage change. * In-depth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP. * Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned. * Excellent project management skills and budget management skills. Preferred Skills: * Proven success working with vendor systems/portals (e.g., eTMF, EDC, IRT,

CTMS)

  • Oncology experience, early and/or late stage, strongly preferred.
  • Knowledge and/or familiarity with Ex-US region(s) clinical trial operations
  • Experience in working with cooperative group studies and investigator
sponsored trials preferred. #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 View email address on click.appcast.io [View email address on click.appcast.io]. Base Pay Salary Range

$186,000—$233,000 USD

-------------------------------------------------------------------------------- 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 View email address on click.appcast.io so we can share these impersonations with our IT team for tracking and awareness. --------------------------------------------------------------------------------

Vacancy posted 4 hours ago
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