Project Director, Dermatology and Rheumatology, CRO, US, remote
Indero
Summary
The Project Director is responsible for oversight of the conduct of a program or portfolio of clinical studies or large global multicentered trials with large study budgets. The portfolio may comprise studies for specific customers, and/or a group of studies within the same therapeutic area or indication for more than one customer. The Project Director oversees Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or portfolio of projects. The Project Director leads the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic and project management expertise.
Job description
This role will be perfect for you if
- You are looking to contribute your expertise to the growth of a specialized CRO
- You are a hands-on leader
- You have at least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management.
- Having experience in dermatology or rheumatology trials is required
Responsibilities
- Oversees a portfolio or program of projects and the Project Managers assigned to operationalize the awarded studies.
- Ensures all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
- Represents company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
- Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations.
- Oversees the management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
- Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
- Ensures and maintains an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
- Applies study specific learning across assigned portfolio of studies/clients.
- Leads and ensures consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
- May lead operational input to proposal development and pricing including proposed operations strategy
- Drives performance improvement, operational efficiencies and innovative strategies
- May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert
Ideal Profile
Education
- Bachelor of Science in a relevant discipline.
- A Master’s degree is an asset.
- PMP or PRINCE2 Certification is an asset
Experience
- At least 15 years industry experience and a minimum of 5 years at a CRO
- At least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, 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
Knowledge and skills
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
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
- Experience managing all project phases from start up to closure
- Experience managing all functional services
- Vendor management experience
- Experience leading concurrent multi-centered, multinational phase III clinical trials
- Project budget financial tracking and forecasting experience
- Substantial experience in project supervision, mentoring and coaching project managers
- Substantial experience with business development tasks such as proposals, client presentations, bid defense meetings
- Dermatology or rheumatology experience is required
- Good knowledge of good clinical practices
- Knowledge of Health Canada and FDA regulations/guidelines
Benefits
- Flexible work schedule
- Home-based position
- Ongoing learning and development
- 401k
- Benefits
- Bonus structure plan
Company overview
Indero is a global Contract Research Organization (CRO) specializing in dermatology and rheumatology clinical research, formerly known as Innovaderm. Founded in 2000 and headquartered in Montreal, Canada, the company has established itself as a world-renowned expert with over 25 years of experience in clinical trial delivery. Indero operates as a dual-focus CRO, providing comprehensive full-service clinical research solutions from protocol design and patient recruitment to trial monitoring and biometrics analysis. The company serves biotech and pharmaceutical sponsors globally with capabilities spanning North America, Europe, Asia Pacific, and Latin America. Indero maintains vast, continuously growing relationships with investigators and patients, and operates a dedicated research clinic where it designs and executes its own studies. The organization has developed innovative approaches to early-phase clinical research, including methods that reduce study duration from traditional 8-12 weeks to just 3 days through microdosing and transcriptomic analysis. Recognized as a Best Employer by Mercer, Indero employs 201-500 professionals and has built a strong reputation for delivering expert, efficient trials while maintaining high standards of quality and patient care.