Director Clinical Operations Rare Disease

Position Summary

We seek an accomplished and highly motivated clinical operations leader to play a pivotal role in driving global clinical development strategies. This individual will serve as a senior leader within the department, overseeing the execution of complex, cross-functional clinical programs in alignment with organizational goals. With a deep understanding of clinical development and a proven track record of leading high-performing teams, the successful candidate will be instrumental in shaping and executing operational strategies that ensure quality, efficiency, and regulatory compliance across therapeutic areas.

This role demands a strategic thinker with exceptional leadership and management experience. The individual must be capable of inspiring teams, optimizing vendor and site performance, and delivering results in a dynamic, fast-paced environment. The individual will collaborate closely with cross-functional teams, investigators, and global partners to ensure the timely and cost-effective execution of clinical studies that support the advancement of the company’s pipeline.

Primary Responsibilities

• Responsible for the development and management of all operational timelines and budgets 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 the 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 the 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

Education/Experience/Skills

A bachelor’s degree in the life sciences, a related field, or an advanced degree is preferred.  Targeting 10 years of clinical development and management experience, with significant clinical trial experience and 8 years of proven experience in a leadership and people management role.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Experience leading and managing complex global clinical development programs is required
• Superior verbal, written, and presentation communication skills in relating to colleagues and associates both inside and outside the organization
• Demonstrated track record of translating senior-level research/scientific business requirements into operational strategies globally
• Has broad experience selecting, managing, troubleshooting, and negotiating with CROs and other vendors
• Thorough understanding of local and international regulations applicable to clinical development; demonstrable knowledge of regulatory requirements globally, and prior success in providing timely and quality support of regulatory submissions
• Practical experience in clinical trial strategies, methods, and processes; deep knowledge of clinical trial design
• Demonstrated technical, administrative, and project management capabilities
• Adept at creating and communicating a clear vision among direct reports, effectively aligning resources, and motivating teams to achieve goals
• Demonstrated analytical abilities and proficient planning and negotiation skills
• Strong interpersonal, organizational, and workload planning skills, along with excellent verbal and written communication skills
• Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output
• Ability to travel 25% of the time

Physical Requirements

This role involves regular standing, walking, sitting, and using hands to handle or operate equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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