Project Director, Early Phase and Translational Research – Europe
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Job Description
Project Director overseeing multinational dermatology and rheumatology clinical trials for specialized CRO Indero. Managing portfolios, budgets, regulatory compliance, and Project Managers across Europe.
Responsibilities:
- Oversee a portfolio or program of clinical studies and the Project Managers assigned to operationalize awarded studies
- Ensure studies reflect therapeutic-area and client-specific requirements
- Represent Indero to customers, maintain satisfaction levels, and communicate program deliverables
- Ensure studies progress according to quality standards, SOPs, GCPs, regulatory requirements, and ICH guidelines
- 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
- Lead 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:
- 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, all functional services, and vendor management
- Experience in dermatology or rheumatology trials is required
- Experience with mid-size and large studies (>10–15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable
- Experience leading concurrent multicentered, 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, including proposal development, client presentations, and bid defense meetings
- Participation in mentoring and coaching of a representative number of project managers
- Bachelor of Science in a relevant discipline
- PMP or PRINCE2 Certification is an asset
- Master's degree is an asset
- Good knowledge of Good Clinical Practices and applicable Health Canada and FDA regulations/guidelines
- Must be legally able to work in Europe
Benefits:
- Flexible work schedule
- Home-based position
- Ongoing learning and development
- Attractive advancement opportunities
- Equitable treatment and equal opportunity
- Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request
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