Nicholas King

• Direct a multinational regulatory science consortium comprising pharmaceutical companies, academic institutions, and global regulatory bodies (FDA, EMA, PMDA), aligning scientific innovation with evolving compliance standards.
• Manage a multi-million-dollar global budget, optimizing financial operations and ensuring compliance with fiscal policies to maximize program value and efficiency.
• Spearheaded biomarker development and qualification initiatives, defining strategic priorities and accelerating regulatory acceptance through cross-sector collaboration.
• Built and led a high-performing international team of scientific, operational, and strategic professionals, cultivating a performance-driven culture.
• Instituted governance structures and performance monitoring frameworks, including KPI systems and reporting dashboards, to ensure transparency and stakeholder accountability across global initiatives.

• Directed regulatory and scientific operations across multiple translational research initiatives, ensuring alignment with international compliance standards and accelerating submission readiness.
• Formulated and executed global regulatory strategies for biomarker submissions, including FDA qualification packages, driving scientific credibility and cross-border approvals.
• Strengthened cross-functional collaboration among partners by implementing streamlined coordination protocols, reducing project cycle times and improving outcome predictability.

• Directed the execution of 10+ biomarker and clinical research projects annually, ensuring adherence to timelines, budgets, and regulatory requirements while maintaining scientific rigor.
• Cultivated strategic partnerships with academic institutions, regulatory agencies, and pharmaceutical collaborators.
• Implemented predictive modeling and workforce planning tools to eliminate resourcing bottlenecks, improving operational efficiency across the program portfolio.
• Standardized project execution by developing SOPs, drafting regulatory submissions aligned with FDA and EMA guidelines, and leading workshops on biomarker science and compliance strategy.

• Directed end-to-end development and regulatory submission of safety biomarkers across preclinical and clinical phases, securing alignment with FDA and EMA qualification pathways.
• Orchestrated multi-stakeholder collaboration among pharmaceutical, academic, and regulatory partners to synchronize submission priorities and drive program acceleration.
• Enhanced project execution by implementing milestone-tracking dashboards, increasing delivery speed and quality across regulatory and research workstreams.
• Guided scientific publication efforts and white paper development, contributing to thought leadership in translational safety science.

• Directed daily operations for more than half the projects in the Predictive Safety Testing Consortium, overseeing planning, budgeting, scheduling, and risk mitigation.
• Led development of project charters, timelines, and risk management frameworks, while conducting root cause analyses to resolve delivery bottlenecks.
• Executed data migration, integrity validation, and audit readiness procedures for large clinical databases.
• Implemented SharePoint and live dashboard systems to boost project transparency, enable real-time tracking, and increase operational efficiency.

• Designed and executed advanced experiments investigating cardiomyocyte mechanics and protein signaling, contributing to NIH-funded research initiatives.
• Authored peer-reviewed publications and developed reproducible laboratory protocols for molecular assays and biophysical investigations.
• Supervised and trained undergraduate and graduate researchers in lab techniques, data integrity, and safety compliance.

Served as an English language educator in Cape Verde, teaching across high school and university levels in multilingual settings. Also coordinated library development and contributed to international development reporting at the Instituto Superior de Educação (ISE).

• Taught high school English as a foreign language to classes of 20–45 students in English, Kriolu, and Portuguese.
• Taught Technical English for Chemistry Teachers at ISE.
• Organized a new English language library and built a checkout database at ISE as library coordinator.
• Edited the annual report for the United Nations Development Program site in Cape Verde.
• Advised an undergraduate on the design and submission of his undergraduate thesis proposal.