Project Director, Dermatology and Rheumatology

Innovaderm Research Inc.  ยท  via Devremote
๐ŸŒŽ Remote ๐Ÿ“ Remote, North Carolina

Job Description:

  • Oversee a portfolio or program of clinical studies and Project Managers assigned to operationalize awarded studies
  • Ensure studies meet therapeutic or client-specific requirements
  • Represent the company to customers and maintain satisfaction levels
  • Communicate program deliverables effectively
  • Ensure studies progress according to quality standards, SOPs, GCPs, ICH guidelines, and applicable regulations
  • Oversee executed contracts and financial aspects, including study budgets and expenses
  • Maintain and evaluate project progress using timelines and tracking/analysis tools
  • Maintain in-depth therapeutic and/or client-specific knowledge for the assigned portfolio
  • Apply study-specific learning across assigned studies and clients
  • Lead contingency planning and risk mitigation strategies
  • Provide operational input to proposal development and pricing, including operations strategy
  • Drive performance improvement, operational efficiencies, and innovative strategies
  • Provide line management oversight and contribute to Project Management leadership as an operational and therapeutic area expert

Requirements:

  • Bachelor of Science in a relevant discipline
  • At least 15 years industry experience
  • Minimum of 5 years at a CRO
  • At least 10 years of clinical project management experience, including management of all project phases from start up to closure, management of all functional services, and vendor management
  • Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable
  • Experience leading concurrent multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting
  • Substantial experience in project supervision, mentoring and coaching project managers
  • Substantial experience with business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like
  • Participation in mentoring and coaching of a representative number of project managers
  • Dermatology or rheumatology experience is required
  • Good knowledge of good clinical practices
  • Knowledge of applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
  • PMP or PRINCE2 Certification is an asset
  • A Masterโ€™s degree is an asset

Benefits:

  • Flexible work schedule / work schedule
  • Home-based position
  • Ongoing learning and development
  • 401k
  • Benefits
  • Bonus structure plan
  • Attractive advancement opportunities