Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
About the role
- Clinical Project Director managing a portfolio of clinical studies to meet client-specific needs at Syneos Health. Ensuring compliance with quality standards and delivering project objectives effectively.
Responsibilities
- Oversee a portfolio or program of projects
- Ensure all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements
- Represent 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
- Manages 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
- Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio
- Apply study specific learning across assigned portfolio of studies/clients
- Lead and ensure 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
- Drive 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
Requirements
- BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements, i.e. GPP
- Strong organizational skills
- Strong ability to manage time and work independently
- Direct therapeutic area expertise
- Proficiency with full MS Office Applications, including MS Project
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Ability to travel as necessary (approximately 25%)
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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