Executive Director, Clinical Pharmacology and Pharmacometrics

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Executive Director of Clinical Pharmacology and Pharmacometrics will provide enterprise-level scientific and strategic leadership for oncology Clinical Pharmacology across Sumitomo Pharma America (SMPA). The role requires deep expertise in clinical pharmacology, pharmacometrics, quantitative drug development, and oncology, combined with strong organizational leadership, scientific judgment, and cross-functional collaboration. The candidate will establish and lead the Clinical Pharmacology and Pharmacometrics strategy across SMPA’s oncology portfolio from translational research and first-in-human (FIH) development through late-stage development, regulatory submission, and lifecycle management. The candidate will integrate PK/PD, exposure-response, biomarkers, target engagement, DDI assessment, and modeling and simulation into development strategies to inform FIH dose selection, dose escalation, recommended Phase 2 dose, dose and regimen optimization, patient selection, combination strategies, and benefit-risk decisions. They will partner closely with SMP, SMPA Oncology Clinical Development, TRMO, DMPK, Toxicology, Biomarkers, Clinical Operations, Regulatory, Biostatistics, Safety, CMC, and Program Management to translate preclinical and translational data into clinically meaningful development strategies. They will provide scientific leadership and oversight for FIH, SAD/MAD, dose escalation and expansion, food-effect, DDI, ADME/mass balance, organ impairment, special-population studies, and other mechanism-based clinical pharmacology activities. A core responsibility will be to establish pharmacometrics and quantitative clinical pharmacology excellence within SMPA, including population PK, PK/PD, exposure-response, model-based drug development, and simulation. They will ensure rigorous integration of pharmacometric analyses with clinical and translational data and provide scientific leadership in modern quantitative methodologies. They will also lead the responsible integration of AI/ML and LLM technologies into Clinical Pharmacology and Pharmacometrics, including capabilities within platforms such as Pumas/Pumas CP. They will ensure AI-enabled approaches enhance modeling, simulation, data interpretation, documentation, and decision-making while maintaining appropriate standards for confidentiality, scientific validity, reproducibility, data integrity, model qualification, and regulatory acceptability. They will establish an effective internal/external operating model, maintaining internal scientific ownership of critical decisions while strategically leveraging CROs, consultants, academic collaborators, and specialized capabilities. The role will include organizational design, recruitment, talent development, succession planning, performance management, governance, and resource management to build a high-performing Clinical Pharmacology organization. They will influence oncology development strategy across the portfolio and provide senior Clinical Pharmacology expertise for business development, licensing, partnerships, and due diligence, including evaluation of external assets, PK/PD and exposure-response data, dose and regimen strategies, combinations, and development risks. They will maintain awareness of emerging quantitative methodologies, technologies, and regulatory expectations and represent SMPA externally through scientific publications, presentations, collaborations, and professional organizations. Essential Functions Required for Job Note: These statements are intended to describe the general nature of the job and are not necessarily an exhaustive list of all responsibilities, skills and duties. Strategic Clinical Pharmacology Leadership Lead the global oncology Clinical Pharmacology and Pharmacometrics strategy across SMPA’s R&D portfolio, integrating Clinical Pharmacology into development plans and portfolio decisions. Serve as a strategic partner to Oncology and TMED from translational research through lifecycle management, providing leadership for program progression, dose/regimen selection, combination development, indication strategy, and quantitative benefit-risk assessment. Identify program risks and opportunities and establish strategies to mitigate risk and maximize asset value. Clinical Pharmacology and Early Development Provide senior Clinical Pharmacology leadership for oncology translational and early clinical development, integrating preclinical PK/PD, pharmacology, target engagement, biomarkers, toxicology, and clinical data to support rational FIH strategies. Provide quantitative leadership for FIH starting dose, dose escalation, exposure targets, dose expansion, and recommended Phase 2 dose selection, incorporating PK/PD, exposure-response, biomarkers, and specialized assessments such as PET/EEG where appropriate. Provide strategic oversight of Phase 1 and clinical pharmacology studies, including FIH, SAD/MAD, food-effect, DDI, organ impairment, ADME/mass balance, and special populations, ensuring studies address critical development questions. Pharmacometrics and Quantitative Drug Development Establish and lead the organization’s pharmacometric strategy, including population PK, PK/PD, exposure-response, modeling and simulation, and model-informed drug development. Apply quantitative approaches to dose selection, trial design, exposure optimization, DDI, special populations, and regulatory decision-making, while maintaining internal scientific ownership of critical conclusions. Establish standards for rigorous, qualified, documented, and reproducible pharmacometric analyses and lead integration of AI/ML and LLM technologies with platforms such as Pumas/PumasAI to enhance modeling, simulation, data exploration, interpretation, documentation, and regulatory activities. Clinical Pharmacology Regulatory Strategy Partner with Regulatory on FDA, EMA, PMDA, ICH, and other global health-authority interactions and provide senior leadership for Clinical Pharmacology content in INDs, CTAs, NDA/BLAs, briefing documents, regulatory responses, and meetings. Provide Clinical Pharmacology leadership for key development documents and strategic regulatory issues involving dose selection, exposure-response, DDI, population PK, modeling and simulation, consistent with evolving regulatory expectations. Organizational and Personnel Leadership Build and lead a high-performing global oncology Clinical Pharmacology organization, establishing appropriate structure, capabilities, operating principles, and performance expectations. Recruit, develop, mentor, and retain high-caliber Clinical Pharmacology and Pharmacometrics scientists while developing future scientific and functional leaders and promoting scientific excellence, collaboration, innovation, integrity, and patient focus