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Global Clinical Operations Manager

2 months ago

Fremont, California, United States Exelixis Full time
Job Summary

The Clinical Operations Director will play a critical role in the success of Exelixis by leading the design, execution, and reporting of clinical trials. This position will be responsible for planning and leading the delivery of studies to time, quality, budget, and company standards.

Key Responsibilities
  • Develop and implement global study delivery strategies to ensure timely and cost-effective delivery of clinical trials.
  • Lead cross-functional teams to develop and execute study plans, including country selection, diversity, patient engagement strategy, and recruitment plan.
  • Collaborate with vendors to ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and Exelixis SOPs.
  • Make decisions that balance risk and benefit, taking action to mitigate risk where necessary.
  • Develop and manage study-level budgets within project allocation.
  • Prepare materials for internal governance and financial review cycles.
  • Build relationships and collaborate with aligned staff in other functions.
  • Lead and conduct investigator meetings and other study-related meetings.
  • Identify and communicate resource gaps for assigned studies.
  • Lead risk management and quality efforts to ensure study compliance and inspection readiness.
  • Contribute to process development, innovative problem-solving, and training initiatives.
  • Provide proactive and consistent oversight of CRO and vendor performance.
Requirements
  • BS/BA and a minimum of 11 years of related experience, or MS/MA degree in a related field and a minimum of 9 years of related experience, or an equivalent combination of education and experience.
  • Experience in the biotech/pharmaceutical industry, preferably in a management role with outsourcing to Contract Research Organizations (CROs).
  • Extensive clinical development experience, including at least 6 years as a global study leader with proven experience in driving operational study delivery.
  • Proven operational experience leading high-performing global study teams in oncology clinical trials.
  • Excellent leadership skills, influencing, and negotiation skills.
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
  • Excellent project management skills and budget management skills.
  • Competent written skills and experience in authoring patient-facing materials, study procedures manuals, pharmacy manuals, and informed consent forms.
Exelixis Leadership Commitments
  • We drive for results, so patients can survive and thrive.
  • We are resilient in the face of adversity, and tireless in advancing our science.
  • We celebrate our long history of prolific drug discovery and rigorous drug development.
  • We unite to launch innovative medicines for difficult-to-treat cancers.
  • We exist to give people hope – one drug, one patient at a time.
Exelixis Core Values
  • Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way).
  • Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results).
  • Excel for Patients (Innovate to design solutions and remove barriers to show how much we care).