Project Manager/Director

Project Manager/Director Job Description

Cybrexa Therapeutics is seeking an experienced, collaborative, and dynamic Project Manager/Director to lead and develop project management for the company’s preclinical and clinical and business operations.

Essential Job Functions and Duties:

  • Proactively works with stakeholders to define and implement projects/initiatives for both scientific and business operations projects (e.g., business development, due diligence)
  • Creates integrated project plans for preclinical and clinical programs, including CMC. Working with a cross-functional team, implements and monitors progress against project plans and revises as necessary
  • Accountable for developing the operational strategy and managing the timelines, budgets, and quality across programs. This includes:
    • Execution of the sourcing/vendor strategy
    • Understanding and planning how different studies fit together (e.g. how the readout from a study informs the next steps and overall program strategy)
  • Proactively engages in both quality assurance and risk management activities to ensure that project deliverables are met according to requirements
    • Responsible for timely issue escalation to appropriate stakeholder(s)
  • Accountable for building, forecasting and managing the program budget
  • Manages, facilitates, and documents key team meetings (e.g., meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making

Knowledge, Skills and Abilities:

  • 5+ years of Project Management experience in Pharma and/or Biotech
  • Thorough understanding of the processes associated with project and study management
  • Experience across preclinical and clinical project management
  • Experience in business operations project management preferred, but not required
  • Extensive experience with clinical trial conduct, US/global clinical trial operations
    • Experience with project managing regulatory filings (e.g., FDA)
  • Ability to work effectively across functions
  • Knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
  • Collaborative communication skills, self-motivated, and capable of balancing multiple workstreams
  • Strong Microsoft Office acumen: e.g., MS Project, Power Point, and Excel
  • PMP certification preferred

Education/Experience

  • The candidate should have at least a BA/BS degree with 5+ years of industry experience in pharma/biotech project management, with demonstrated strong contributions to projects
  • PhD in a scientific discipline is preferred
  • Previous experience in working in project management for preclinical programs and clinical programs