Associate Director, Clinical Operations

August 30, 2019

Associate Director, Clinical Operations

Location: Buffalo Grove, IL

Classification – Full-time position

We are looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced start-up environment and contributing to our growth. Associate Director, Clinical Operations will be a key contributor within Clinical Operations and reports to the Head of Clinical Operations.

Position Objectives:

  • Provide oversight and direction of CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to CRO/vendor for assigned program.
  • Provide input in the financial planning/forecasting and budget management for a given program.
  • Oversight of CRO/Vendors providing strategic input to ensure goals and deliverables are met with quality per contracted scope of work and to meet Phathom’s obligations described in ICH/GCP.
  • Provide program level direction to Clinical Operations staff for the development of study management plans including enrollment models and risk management and communication plans, monitoring plans in collaboration with CRO.

Primary Accountabilities:

  • Oversee operational strategy for clinical programs, including risk management and contingency planning.
  • Oversee overall program execution of assigned clinical program and clinical studies to deliver high-quality, on time, on budget deliver of clinical trials to meet the drug development objectives.
  • Overseeing the management of program budget planning/forecasting, and accountable for external spend related to program execution.
  • Work closely with Finance to ensure on a regular basis that budgets, enrollment, and forecasting are accurate; Communicates program status, cost and issues to ensure timely decision-making by senior management.
  • Manage/escalate significant issues related to quality, timelines and budget and provide recommendations.

Qualifications:

  • Bachelor’s Degree Required, preferably in Life Sciences degree; Advanced degree preferred
  • Minimum 10 years of applicable clinical operations experience in a multi-disciplinary environment, including minimum 6 years of line and/or matrix management experience.
  • Experience in multiple therapeutic areas and experience in a matrix organization is preferred.
  • Proven success in effectively managing external clinical research organizations/partners including vendors and investigators is required.
  • Expert knowledge and experience of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP, including experience with global regulations and global regulatory inspections is required.  Familiarity with industry interpretations to ensure compliance while reducing complexity is preferred.
  • Previous global/international experience required.
  • Excellent communicator with strong written and verbal presentation skills, including fluent business English skills (oral and written).
  • Strong leadership capability with advanced skills in team building, motivating, and developing people.

 

To apply for this opening, please submit your resume to careers@phathompharma.com.