Sr. Director, Clinical QA

Neurocrine Biosciences • San Diego, CA

32d • $223,300 - $305,000

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. This role is responsible for developing and leading the strategy and operational plans for Clinical QA and contributing to broader Quality and organizational strategy. It provides strategic leadership for clinical quality and GCP compliance across the clinical development portfolio and establishes the long-term direction, capabilities, processes, and quality systems necessary to support business objectives. The position leads Clinical QA activities and teams responsible for ensuring compliance and effective quality oversight of clinical development activities. The Sr. Director serves as a senior Quality advisor to Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other key stakeholders, providing strategic guidance on complex and emerging compliance matters. This role leads the company through regulatory inspections and provides strategic oversight of clinical audits, inspection readiness, quality risk management, and the clinical Quality Management System (QMS). It establishes organizational priorities, resource plans, budgets, and performance objectives and develops talent and organizational capabilities to meet current and future business needs.

Requirements

• RN, BSN, BS/MS, BA degree, or equivalent experience in a scientific or health care field AND 14+ years of applicable industry experience, including significant GCP leadership experience within development and/or commercial environments.
• Extensive GCP audit, inspection, clinical quality systems, and regulatory compliance experience required.
• Demonstrated experience developing and implementing GCP QA systems, processes, and procedures.
• Significant people leadership experience required.
• Master's degree in a similar field as noted above AND 12+ years of applicable experience as noted above.
• PhD in a similar field as noted above AND 10+ years of applicable experience as noted above.
• Recognized as an internal thought leader with deep technical and business expertise and the ability to become a company-wide advisor and emerging external industry expert.
• Demonstrated ability to develop and implement multi-year strategies and translate strategic direction into executable operational plans, priorities, and measurable outcomes.
• Expert knowledge of own function with broad understanding of related functions and the ability to integrate multiple disciplines and perspectives to address complex business and scientific challenges.
• Demonstrated ability to lead through highly complex, ambiguous, and novel situations and develop innovative solutions with significant functional and cross-functional impact.
• Strong strategic mindset with the ability to anticipate emerging business, regulatory, and industry trends and incorporate them into long-term plans and organizational priorities.
• Exceptional interpersonal, executive communication, and influencing skills, including the ability to communicate effectively with senior leadership, regulatory authorities, external partners, and diverse cross-functional stakeholders.
• Demonstrated ability to influence significant decisions across organizational boundaries and build alignment among stakeholders with differing priorities and perspectives.
• Proven leadership skills with the ability to effectively lead, develop, mentor, and motivate leaders and professional staff to achieve strategic and operational objectives.
• Demonstrated ability to build high-performing teams, strengthen organizational capability, develop talent, and establish succession and development plans for critical roles.
• Strong decision quality and judgment, including the ability to assess complex risks, integrate diverse perspectives, and make timely decisions with long-term organizational implications.
• Demonstrated ability to establish clear accountability for outcomes and create an environment focused on execution, continuous improvement, ethical conduct, and sustained high performance.
• Ability to serve as a trusted advisor and advocate for Quality while balancing compliance, patient safety, business objectives, and organizational priorities.
• Expert knowledge of clinical trial-related FDA regulations, ICH Guidelines, and international GCP regulations and guidelines.
• Extensive experience developing and overseeing comprehensive, risk-based audit and compliance programs for investigator sites, CROs, clinical laboratories, vendors, and other clinical research partners supporting Phase I-IV studies.
• Expert knowledge of auditing principles, techniques, inspection readiness, regulatory inspection management, quality risk management, and corrective and preventive action processes.
• Extensive experience interacting with regulatory authorities and leading or providing senior Quality leadership for regulatory inspections and inspection readiness activities.
• Broad and deep understanding of domestic and international regulations and guidance documents, including FDA and EMA requirements and evolving global expectations for clinical research and GCP compliance.
• Extensive pharmaceutical and/or biotechnology and/or medical device industry experience with deep knowledge of quality systems and regulatory compliance requirements applicable to clinical development.
• Expert knowledge of GCP requirements and strong working knowledge of GLP and/or GMP systems throughout the product lifecycle.
• Demonstrated ability to develop, implement, and continuously improve clinical quality systems, processes, procedures, governance, and risk-based compliance strategies.
• Demonstrated ability to assess complex clinical quality and compliance risks, identify systemic or emerging trends, and develop strategic approaches that appropriately balance regulatory requirements and business objectives.
• Proven ability to establish productive relationships with senior cross-functional leaders, regulatory authorities, clinical investigators, CROs, vendors, and external partners.
• Demonstrated success leading and developing Clinical QA organizations and/or teams, including developing leaders and building organizational capabilities to support evolving business needs.
• Expert ability to manage multiple complex workstreams and priorities in a dynamic development environment while maintaining focus on long-term strategy and organizational outcomes.

Responsibilities

• Develops and leads multi-year strategy and operational plans for Clinical QA aligned with Quality, R&D, and company objectives.
• Provides strategic leadership for GCP quality and compliance across the clinical development portfolio and champions a strong Quality Culture throughout the organization.
• Serves as a senior Quality advisor and strategic partner to Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other functional leaders regarding complex compliance issues, emerging risks, and interpretation of global GCP regulatory requirements and expectations.
• Leads the development and evolution of the Clinical QA vision, goals, core capabilities, operating model, and long-term roadmap to support evolving business, portfolio, and regulatory needs.
• Provides strategic leadership and oversight for regulatory inspection readiness and regulatory inspections, including inspection readiness planning, mock inspections, pre-approval inspections, responses to regulatory authorities, and risk-based management of inspection-related quality events.
• Directs the development, implementation, governance, and continuous improvement of the clinical QMS, ensuring systems and processes remain effective, scalable, risk-based, and aligned with evolving global regulatory expectations and business needs.
• Establishes and oversees risk-based audit and compliance strategies for global clinical investigators, contract clinical laboratories, CROs, vendors, and other external partners.
• Provides strategic oversight of investigator and vendor compliance and ensures significant quality or compliance risks are appropriately escalated, assessed, and remediated through effective corrective and preventive actions.
• Provides Quality leadership and strategic guidance supporting investigational new drug applications, ex-US clinical trial applications (CTAs), marketing applications, and related correspondence and interactions with global regulatory authorities.
• Establishes meaningful quality metrics, trends, and risk indicators for Clinical QA and communicates insights, emerging risks, and recommendations to senior leadership to support informed decision-making.
• Directs and oversees compliance activities related to drug safety and pharmacovigilance, Phase IV studies, investigator-initiated trials, and other clinical development activities within the scope of Clinical QA.
• Provides strategic oversight of internal audit activities designed to assess whether policies, procedures, systems, reporting, and conduct of investigational studies comply with applicable GCP principles, regulations, and company requirements.
• Anticipates changes in the global regulatory and external environment and evaluates their potential impact on clinical development, Quality strategy, systems, and organizational capabilities.
• Partners across functions to resolve complex or ambiguous quality and compliance issues with significant business, regulatory, or portfolio impact and influences senior leaders regarding appropriate risk-based decisions.
• Leads, develops, and mentors Clinical QA leaders and team members.
• Establishes and manages Clinical QA resource plans, budgets, priorities, and external partnerships to ensure effective execution of strategic and operational objectives.
• Represents Clinical QA and Neurocrine, as appropriate, in interactions with regulatory authorities, external partners, industry organizations, and other external stakeholders.
• Other duties as assigned.

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director