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About the Role

Responsible for developing strategic plans, objectives, and overall management for the Clinical Operations team executing Neurocrine's clinical studies across all phases. Ensures compliance with regulations and SOPs, oversees CROs and vendors, and manages career development for direct reports.

Responsibilities

• Design and implement clinical strategies using internal and external resources.
• Provide leadership to the Clinical Operations study team.
• Lead the tactical implementation and execution of the clinical development process.
• Ensure activities are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and SOPs.
• Establish and manage overall clinical program and individual study budgets.
• Develop and maintain clinical trial timelines to achieve corporate goals.
• Create and establish critical metrics to benchmark activities and maintain high standards.
• Identify and introduce process improvements within the clinical organization.
• Manage relationships and expectations with CROs and other clinical contract service providers.
• Manage inter-department relationships to ensure adequate support for clinical programs.
• 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.
• Manage operational activities of clinical programs with corporate partners.
• Perform additional tasks and duties as assigned.

Requirements

• BS/BA degree in a scientific or related field AND 12+ years of extensive experience in clinical research in the pharmaceutical/biotech industry, or CRO, or relevant experience.
• Master's degree in a scientific or related field or MBA AND 10+ years of similar experience.
• Extensive previous managerial experience.
• Detailed knowledge of the clinical drug development process, including ICH, GCPs, FDA regulations, and EU directive.
• Ability to effectively manage, mentor, and train personnel, and 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 with CROs or similar complexity.
• Recognized as an internal thought leader with extensive technical and business expertise.
• Applies in-depth knowledge of own function, business/commercial/scientific expertise to solve critical issues.
• Evaluates key business/scientific challenges and completes complex, ambiguous initiatives with 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 and influencing skills.

Skills

• Clinical drug development process
• ICH
• GCPs
• FDA regulations
• EU directive
• Global studies management
• Endocrine indications
• Rare diseases
• Vendor management
• CRO management
• Leadership
• Mentoring
• Training
• Negotiation
• Influencing
• Organizational skills
• Interpersonal skills

Experience Level

• 12+ years of extensive experience
• 10+ years of similar experience
• Extensive previous managerial experiences

Education Level

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

About the Company

• Neurocrine Biosciences is a leading biopharmaceutical company focused on relieving suffering for people with great needs.
• Dedicated to discovering, developing, and commercializing life-changing treatments for neurological, psychiatric, endocrine, and immunological disorders.
• Possesses a diverse portfolio of FDA-approved treatments and a robust pipeline.
• Applies unique insight into neuroscience and brain-body systems for over three decades.
• Relentlessly pursues medicines to ease the burden of debilitating diseases and disorders.
• Strong leadership drives business results and team success, fostering an environment where people are motivated to do their best work.

Equal Opportunity

• Neurocrine Biosciences is an EEO/Disability/Vets employer.
• Committed to building a workplace of belonging, respect, and empowerment.
• Encourages applications even if experience or qualifications don't align exactly with the job description.