Senior Manager, Clinical Program Manager

August 30, 2019

Senior Manager, Clinical Program Manager

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.  Senior Manager, Clinical Program Manager will be a key contributor within Clinical Operations and reports to the Head of Clinical Operations.

Position Objectives:

  • Lead and/or oversee the execution of clinical studies for an assigned clinical study/program, supporting the clinical strategy defined in the Development Plan (DP).
  • Manage multiple highly complex projects within a study/program or across programs.
  • Manage program/study budget including forecasting; accountable for external spend related to program execution.
  • Management of Clinical Research Organization and other vendors to ensure goals and deliverables are met with quality per contracted scope of work and to meet Phathom’s obligations described in ICH-GCP and Phathom’s business objectives.

Primary Accountabilities:

  • Plan and manage the overall execution of assigned clinical study/program(s) to meet drug development which may involve managing a portfolio of projects and programs.
  • Consistently deliver high-quality, on time, on budget, including making or recommending operational strategies and/or decisions (with input from Clinical Operations leadership) in support of achieving clinical program objectives.
  • Manage program budget and 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 vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to CRO/vendor for assigned program, including escalation of issues when warranted.
  • Responsible for operational risk management strategy in collaboration with CRO and effectively communicate when deliverables are at risk.

Qualifications:

  • Bachelor’s Degree required; Advanced degree preferred
  • Minimum 8 years of applicable clinical operations experience in a multi-disciplinary environment, including minimum 4 years of line and/or matrix management experience.
  • Experience in multiple therapeutic areas and experience in a matrix organization is required.
  • Proven success in effectively managing external clinical research organizations/partners including vendors and investigators is required.
  • Expert knowledge 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.
  • Global/international experience preferred, including ability to collaborate with colleagues and staff in other locations.
  • 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.