Director, Clinical Operations - Vendor Management

Role Summary

Director, Clinical Operations - Vendor Management responsible for developing strategic plans, objectives and overall management for the Clinical Operations team executing Neurocrine's clinical studies (all phases). Ensure activities comply with FDA regulations, EU Directive, ICH guidelines, and SOPs. Focus on oversight of CROs, external vendors and internal stakeholders to meet timelines, budgets, and resources to achieve program objectives and corporate goals. Manage career development of multiple direct reports within clinical operations.

Responsibilities

• Design and implement clinical strategies using internal and external resources
• Provide leadership to the Clinical Operations study team (Associate Directors, Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees)
• Lead the tactical implementation and execution of the clinical development process (all phases) primarily for selected programs
• Ensure activities are conducted in compliance with FDA regulations, EU Directive and ICH guidelines, and SOPs
• Establish and manage overall clinical program budgets as well as individual study budgets
• Develop and maintain clinical trial timelines to achieve corporate goals
• Create and establish critical metrics to benchmark activities to develop and revise performance to reach and maintain highest possible standards of excellence
• Identify and introduce process improvements within the clinical organization
• Manage relationships and expectations with CROs and other clinical contract service providers; act as point of contact with external bodies
• Manage inter-department relationships (Regulatory, QA, etc) to ensure adequate support for clinical programs and contribute to cross-functional meetings and documentation
• Interface with Medical Directors by providing operational input to clinical protocols, development plans and study reports
• Recruit, train, and manage career development of multiple direct reports within the clinical operations group
• Manage operational activities of clinical programs with corporate partners
• Perform additional tasks and duties as assigned

Qualifications

• BS/BA in scientific or related field and 12+ years of experience in clinical research in pharma/biotech or CRO; knowledge of ICH, GCPs, FDA regulations, and EU directive; prior experience directing global studies, especially in endocrine indications and/or rare diseases, or
• Master's degree or MBA and 10+ years of similar experience; extensive managerial experience
• Internal thought leader with extensive technical and business expertise within a strategic organization
• Ability to solve critical issues independently and innovatively; cross-functional impact
• Ability to work independently and collaborate across diverse teams; operate in a multi-level matrix environment
• Strong organizational, interpersonal, and leadership skills; negotiation/influencing skills
• Detailed knowledge of clinical drug development process and regulatory requirements
• Ability to mentor and train personnel and motivate teams to achieve goals
• Strategic vendor management skills, particularly with CROs or similar complexity

Skills

• Leadership of clinical operations teams
• Vendor and CRO management
• Clinical program budgeting and timeline development
• Regulatory compliance (FDA, EU, ICH, GCP)
• Cross-functional collaboration and stakeholder management
• Operational input to protocols, development plans, and study reports

Education

• BS/BA in scientific or related field; or Master's degree/MBA

Additional Requirements

• Experience with global studies and special populations (endocrine/rare diseases) preferred