Project Director, Dermatology and Rheumatology
Innovaderm Research Inc. ยท via
Devremote
๐ Remote
๐ 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 Masterโs 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