Sr. Director, Clinical QA
Neurocrine Biosciences
Summary
Responsible for developing and leading the strategy and operational plans for Clinical QA and contributing to broader Quality and organizational strategy. 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.
Job description
Your Contributions
- 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.
- Serves as a senior Quality advisor and strategic partner to Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other functional leaders.
- Leads the development and evolution of the Clinical QA vision, goals, core capabilities, operating model, and long-term roadmap.
- Provides strategic leadership and oversight for regulatory inspection readiness and regulatory inspections.
- Directs the development, implementation, governance, and continuous improvement of the clinical QMS.
- 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.
- Provides Quality leadership and strategic guidance supporting investigational new drug applications, ex-US clinical trial applications (CTAs), marketing applications, and related correspondence.
- Establishes meaningful quality metrics, trends, and risk indicators for Clinical QA.
- Directs and oversees compliance activities related to drug safety and pharmacovigilance, Phase IV studies, investigator-initiated trials, and other clinical development activities.
- Provides strategic oversight of internal audit activities.
- Anticipates changes in the global regulatory and external environment and evaluates their potential impact.
- Partners across functions to resolve complex or ambiguous quality and compliance issues.
- Leads, develops, and mentors Clinical QA leaders and team members.
- Establishes and manages Clinical QA resource plans, budgets, priorities, and external partnerships.
- Represents Clinical QA and Neurocrine in interactions with regulatory authorities, external partners, industry organizations, and other external stakeholders.
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.
- OR Master's degree in a similar field AND 12+ years of applicable experience.
- OR PhD in a similar field AND 10+ years of applicable experience.
- 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.
- 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.
- 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.
- Expert ability to manage multiple complex workstreams and priorities in a dynamic development environment.
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Paid Personal Days
- Paid Caregiver Leave
- Paid Parental Leave
- Paid Medical Leave
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
- Annual Bonus
- Equity Long-Term Incentive
Company overview
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company founded in 1992 and headquartered in San Diego, California. The company specializes in discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Neurocrine's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Their flagship product, INGREZZA (valbenazine), was the first FDA-approved treatment for adults with tardive dyskinesia. The company maintains a robust pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas, including Parkinson's disease, Tourette syndrome, and major depressive disorder. Neurocrine operates with a purpose to relieve suffering for people with great needs, applying unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions. The company is publicly traded on NASDAQ under the symbol NBIX and has established strategic collaborations with major pharmaceutical partners including AbbVie.