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Senior Director, Clinical Operations - Oncology

Company: Ascendis Pharma
Location: Palo Alto
Posted on: January 16, 2022

Job Description:

  • Provide strategic and tactical insights on clinical operational aspects to the clinical development plans for Ascendis' oncology programs
  • Plan and lead end-to-end clinical operational activities to ensure efficient and high-quality clinical trial execution. Accountable for related corporate and departmental goals.
  • Line management of Clinical Operations staff; ensure sufficient resources to support new and ongoing clinical activities.
  • Responsible for the department's employee's personal development and training.
  • Ensure clinical activities are conducted according to internal and external guidelines.
  • Contribute to Ascendis' clinical Quality Management System.
  • Day to day line management of Clinical Operations employees; including conducting team meetings and 1:1s
  • Arrange meetings, as needed, with relevant peers in and outside Clinical Operations
  • Participate in Clinical Operations Management meetings
  • Participate in project meetings, including Project Core Team meetings, as relevant
  • Solicit support from Clinical Development, Medical Affairs, and other relevant functions to identify investigational sites
  • Budgeting and follow-up in line with current Finance processes
  • Participate in vendor governance meetings, as needed
  • Identify and ensure resolution of project and trial level issues
  • Escalate project and collaboration issues to VP Clinical Operations if necessary
  • Propose measures and initiatives that will ensure continuous improvement of the Ascendis clinical trial processes
  • Lead or participate in improvement projects within Clinical Operations or adjacent functions
  • Coordinate or write clinical SOPs and Working Instructions
  • Maintain up-to-date knowledge on clinical trial methodology and trends
  • Act as delegate for the VP of Clinical Operations as needed
  • Travel approximately 10-15%

    Requirements
    • Minimum BSc or MSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
    • At least 12 years of experience within clinical operations; minimum 6 of these within oncology
    • Minimum 5 years of direct or indirect line management experience
    • Experience with all phases in clinical trial conduct; setup, maintenance and closure
    • Strong understanding of adjacent key functions, including medical, biostatistics, data management, regulatory affairs and clinical trial supplies
    • Deep understanding of the drug development process
    • Ability to drive individuals and teams in a respectful way
    • Confident decision maker
    • Structured, organized and a proactive problem-solver, striking the right balance between detail and progress
    • Strong writing, communication and presentation skills
    • Experience leading and working in global/virtual teams
    • New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law

      Benefits
      • Medical insurance
      • Vision insurance
      • Dental insurance
      • 401(k)
      • Paid maternity leave
      • Paid paternity leave
      • Commuter benefits
      • Disability insurance

Keywords: Ascendis Pharma, Palo Alto , Senior Director, Clinical Operations - Oncology, Healthcare , Palo Alto, California

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