Director, Clinical Development Operations
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Job Description
Director leading clinical development operations, process optimization, and global project management systems at Syneos Health. Supporting drug development and commercialization through integrated life sciences services.
Responsibilities:
- Lead technical strategy for the FSP Enablement Team
- Direct and manage business operations, ensuring Trusted Process methodology, project management standards, and SOPs are optimized and consistently implemented
- Ensure internal and customer quality standards, GCP, and ICH guidelines are fulfilled
- Provide strategic and operational planning
- Drive continuous process improvement across the company
- Manage and provide leadership to Syneos Health, including supervision of senior management positions in the assigned business unit and region
- Participate in short- and long-term planning for department operations and growth
- Lead forecasting, planning, and logistics for clinical operations activities
- Review performance and recommend quality and efficiency improvements
- Lead or oversee assigned business and strategic improvement initiatives
- Manage staff through professional development, performance appraisals, counseling, goal-setting, and delegation
- Support regional staff planning and talent acquisition in the assigned country
- Liaise between operations departments and clinical business units
- Refine project management processes and lead subject matter experts in developing and reviewing SOPs and work instructions
- Support enterprise-wide project management systems and tools
- Evaluate project progress and distribute resource status reports and functional area plans
- Develop, collect, and analyze project metrics
- Oversee project reviews focused on budget, schedule, and risk analysis
- Lead global project management systems and processes and plan resource allocation
- Manage departmental human resources and administrative matters
- Interview candidates and support professional meetings or seminars
- Establish and maintain training materials
- Provide input to long-range IT and enterprise plans
- Perform other assigned work-related duties
Requirements:
- BA/BS degree or equivalent combination of education and experience
- Management experience, preferably in a worldwide clinical research, pharmaceutical, or biotechnology company
- Management skills and experience, including short- and long-term planning, staff evaluation, directing and motivating staff, marketing, and financial management
- Highly required clinical research background
- Thorough knowledge of ICH GCP and general regulatory authority requirements, drug development, and clinical project management procedures
- Ability to engage diverse interests and communicate and work with diverse individuals to accomplish common goals
- Strong leadership, tactical and strategic thinking skills
- Ability to anticipate and address critical issues and develop contingency plans proactively
- Knowledge of financial concepts related to forecasting, budgeting, and proposal generation
- Ability to self-direct tasks and set direction and priorities for others
- Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Desired technology experience with PowerApps, PowerBI, SharePoint, Oracle, Copilot agent building, financial review, dashboards, and enterprise-level technology
- Experience working in a matrix team environment is preferred
- Membership and/or affiliations with applicable professional organizations are highly preferred
- Some travel may be required, up to 25%
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate
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