Director, Clinical Operations - Vendor Management

Role Summary

Responsible for developing strategic plans, objectives and overall management for Clinical Operations team executing Neurocrine's clinical studies (all phases). Ensure clinical study activities are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and are in adherence with corporate and departmental Standard Operations Procedures. A key focus will be on the oversight of CROs, external vendors and internal stakeholders to ensure studies are conducted according to timelines, budgets, and resources to achieve program objectives and corporate goals. The Director will also manage career development of multiple direct reports within clinical operations group.

Responsibilities

• Design and implement clinical strategies using internal and external resources
• Provides 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 these activities are conducted in compliance with FDA regulations, EU Directive and ICH guidelines, and are in adherence with corporate and departmental Standard Operating Procedures (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 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 as well as provide input into cross functional meetings and documentation
• Interface with Medical Directors by providing operational input to clinical protocols, clinical development plans and clinical 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 degree in scientific or related field AND 12+ years of extensive experience with traditional progression in clinical research in pharmaceutical/biotech industry, or CRO or relevant experience required. Experience in clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive also required. Prior experience directing global studies, particularly in endocrine related indications and/or rare diseases. OR
• Master's degree in scientific or related field or MBA AND 10+ years of similar experience shown above. OR
• Extensive previous managerial experiences also required
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
• Ability to work independently and cooperate and collaborate with a wide variety of individuals, groups, and teams
• Ability to effectively operate in a multi-level matrix environment
• Strong organizational, interpersonal and leadership skills
• Strong internal/external negotiation / influencing skills
• Detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive
• Ability to effectively manage, mentor and train personnel and ability to motivate and influence personnel to achieve goals
• Expertise directing global studies, particularly in endocrine related indications and/or rare diseases
• Strategic vendor management skills, particularly CROs or similar complexity

Skills

• Leadership and people management
• Vendor and CRO management
• Clinical development planning and budgeting
• Regulatory compliance (FDA, ICH, GCP, EU directives)
• Program and project management in a matrix environment

Education

• BS/BA or MS/MBA in scientific or related field