Director Clinical Operations Rare Disease

Director Clinical Operations Rare Disease

Requirements

• Bachelor’s degree in the life sciences or related field; Advanced degree preferred
• Targeting 10 years’ clinical development and management experience
• Significant clinical trials experience
• 8 years’ proven experience in a leadership and people management role
• Experience leading and managing complex global clinical development programs is required
• Thorough understanding of local and international regulations applicable to clinical development; demonstrative knowledge of regulatory requirements globally
• Practical experience in clinical trial strategies, methods and processes; deep knowledge of clinical trial design
• Demonstrated technical, administrative, and project management capabilities
• Ability to travel 25% of the time

Responsibilities

• Responsible for the development and management of all operational timelines and budget for programs under the respective therapeutic area
• Responsible for providing operational input for development plans in support of the asset strategy
• Represent the respective therapeutic area for senior management as needed
• Leads the strategy and tactics to successfully work with vendors, investigators, other departments within ACADIA, and the program clinicians to develop, execute and deliver clinical programs supporting drug development while ensuring quality speed, budget, and regulatory compliance
• Evaluates, refines, and makes recommendations for various operational constructs for study execution
• Leads and shares best practices with internal and external stakeholders, as appropriate
• Establishes performance, quality, business efficiency and innovation metrics for clinical teams; addresses systematic deficiencies and seeks to improve quality across study programs
• Maintains awareness of industry trends and developments to help define the future strategic direction for the clinical programs
• Provides direction in the development and oversight of study plans to ensure quality processes are followed
• Responsible for direct management of Clinical Operations team members in the respective therapeutic area to ensure consistent application of best practice and execution
• Supports mentoring and training of Clinical Operations staff in the respective therapeutic area
• Participates in and/or leads process improvements within/between cross functional areas to increase efficiencies and manage costs
• Develops and measures appropriate metrics to assess and improve vendor and site performance
• Ensures that cross-functional process efficiencies are identified and maximized in accordance with project goals
• Oversees and is accountable for appropriate resource planning to support specific therapeutic area
• Participates in the selection, management and oversight of CROs and other vendors, driving quality performance to milestones and deliverables
• Other responsibilities as required

Preferred Qualifications

• Advanced degree preferred
• An equivalent combination of relevant education and experience may be considered