Eliassen Group
Eliassen Group

Director, Clinical Operations - Phase III Oncology

Remote in Anywhere, US • Posted 8 hours ago • Updated 8 hours ago
Contract W2
Remote
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Job Details

Skills

  • Life Insurance
  • Data Management
  • Biostatistics
  • Decision-making
  • Reporting
  • Database
  • Accountability
  • Clinical Research
  • NDA
  • Pivotal
  • Management
  • Budget
  • Recovery
  • Google Cloud
  • Google Cloud Platform
  • Inspection
  • Documentation
  • Onboarding
  • Leadership
  • Collaboration
  • Screening
  • Artificial Intelligence
  • Recruiting
  • Taxes
  • Insurance
  • Law
  • Communication
  • Gmail
  • Routing
  • Management Consulting
  • Life Sciences
  • SAP BASIS
  • Military

Summary

Description:
Remote

Our client is seeking a Director, Clinical Operations to lead the operational execution of a large global Phase III breast cancer study. The role will drive study start-up, site activation, vendor oversight, and cross-functional coordination across approximately 30 countries and 400 sites, advancing the program through key milestones toward database lock and regulatory submission. The Director will report to the VP of Clinical Operations and will operate in a fast-moving environment with established infrastructure from a prior Phase III breast cancer study using the same CRO and some overlapping sites.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Rate: $150.00 to $160.00/hr. w2

Responsibilities:
  • Lead operational execution of a global Phase III breast cancer study from start-up through regulatory milestones.
  • Drive study start-up across ~30 countries and ~400 sites with tracked and achieved timelines.
  • Provide sponsor oversight of CROs and vendors with clear expectations, deliverables, accountability, and escalation.
  • Hold CROs accountable for contractual performance, milestones, quality, enrollment, and timelines.
  • Identify risks and bottlenecks early and implement mitigation strategies.
  • Coordinate cross-functional activities with Clinical Development, Data Management, Biostatistics, Regulatory, Safety, and Quality.
  • Establish and monitor study-level metrics, milestones, risks, dependencies, and vendor performance.
  • Oversee global site activation and start-up strategy.
  • Drive operational decision-making with urgency appropriate for a pivotal program.
  • Maintain inspection-readiness and documentation standards.
  • Manage CRO and vendor escalation and intervene when performance or timelines are at risk.
  • Provide concise status and risk reporting to Clinical Operations and senior leadership.
  • Advance the study toward database lock and NDA/BLA submission.
  • Operate effectively in a fast-moving biotech environment with high accountability.

Experience Requirements:
  • 10+ years of progressive Clinical Operations or clinical research experience with significant sponsor-level leadership of global trials.
  • Oncology experience required; breast cancer experience strongly preferred.
  • Demonstrated leadership of large global Phase III studies across multiple regions.
  • Direct experience leading a global Phase III study through late-stage execution and successful NDA and/or BLA submission.
  • Proven experience taking a pivotal study over the finish line.
  • Deep experience with study start-up and global site activation for complex late-stage trials.
  • Extensive experience managing and overseeing global CROs and vendors.
  • Ability to challenge CRO performance, escalate issues, and drive aggressive timelines and deliverables.
  • Experience managing studies of significant size, complexity, enrollment, site footprint, and budget.
  • Ability to anticipate study risks and implement mitigation and recovery strategies.
  • Strong knowledge of ICH/Google Cloud Platform, inspection readiness, documentation, and global trial requirements.
  • Ability to assume ownership with minimal ramp-up or onboarding.
  • Strong leadership, communication, organizational, and cross-functional collaboration skills.
  • Comfort operating in an execution-focused environment with aggressive timelines.


Recruitment Transparency Notice



Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.

Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:

When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.

Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.

If you have any indication of fraudulent activity, please contact .

About Eliassen Group:

Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.

Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.

Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: cxelisen
  • Position Id: a1WUQ000001zQQ12AM
  • Posted 8 hours ago

Company Info

About Eliassen Group

Eliassen Group is a leading strategic consulting company that provides business and IT services for our clients as they seek to transform and execute strategies that will drive exceptional outcomes. Leveraging over 30 years of success, we focus on professional services, talent solutions, and life sciences. Eliassen Group offers local community presence and deep networks. We are committed to positively impacting the lives of our employees, clients, consultants, and the communities in which we operate.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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