US-Remote Full time R01497 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

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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. _External Partners and Resource Management_ + Establish the strategic outsourcing model for clinical pharmacology, pharmacometrics, and specialized quantitative activities and manage CROs, consultants, academic collaborators, and other external partners. + Ensure appropriate scientific, regulatory, quality, budget, and timeline performance while maintaining internal scientific ownership and governance of critical-path activities. _Business Development, Due Diligence and Lifecycle Management_ + Provide senior Clinical Pharmacology expertise for oncology business development, licensing, acquisitions, partnerships, and due diligence, evaluating PK/PD, exposure-response, dose/regimen selection, DDI, biomarkers, therapeutic index, and development risk. + Provide recommendations to senior leadership on the quantitative strengths, limitations, opportunities, and risks of potential assets. + Lead Clinical Pharmacology strategy from Phase 1 through registration and post-approval, including label expansion, new indications, formulation changes, dose optimization, and other lifecycle activities. _Scientific Leadership and External Representation_ + Serve as a senior scientific expert and representative of SMPA in oncology Clinical Pharmacology, maintaining awareness of advances in pharmacometrics, biomarkers, quantitative drug development, and emerging technologies. + Represent SMPA through publications, presentations, scientific collaborations, professional organizations, and external forums, and establish relationships with external experts and academic institutions.

• Knowledge and skills (general and technical):
• + Deep understanding of oncology drug discovery and development and the role of Clinical Pharmacology in translational and clinical decision-making.

+ Extensive experience with oncology FIH and Phase 1 development, including dose escalation, SAD/MAD, dose optimization, DDI, organ impairment, ADME, and special populations. + Thorough knowledge of PK, PK/PD, exposure-response, population PK, pharmacometrics, modeling and simulation, and model-informed drug development. + Strong understanding of oncology therapeutic index, dose optimization, biomarkers, target engagement, and combination therapy development. + Proficiency with Phoenix WinNonlin and advanced pharmacometric platforms, including NONMEM, Pumas or comparable tools. + Experience in applying AI/ML and/or LLM-enabled technologies to quantitative drug-development workflows, preferably including integration with pharmacometric software and modeling environments. + Broad understanding of drug discovery and development including DMPK, toxicology, translational medicine, clinical development, clinical operations, biomarkers, biostatistics, regulatory affairs, CMC, and program management. + Demonstrated ability to recognize opportunities to improve the efficiency and quality of oncology drug development. + Strong knowledge of global regulatory expectations and industry best practices related to Clinical Pharmacology + Strong strategic thinking, scientific judgment, problem-solving, negotiation, and decision-making skills. + Excellent communication skills with scientists, clinicians, regulatory professionals, senior R D leaders, and external partners. + Proven ability to lead effectively in a global, matrixed, and cross-cultural organization.

• Education Level and/or Relevant Experience
• + For the Executive Director position, a PhD, PharmD, or equivalent advanced scientific degree in Clinical Pharmacology, Pharmaceutics, Pharmacology, Pharmaceutical Sciences, or a related field is required.

+ Advanced formal education and/or substantial professional training in pharmacometrics is required, together with demonstrated expertise in population PK, PK/PD, exposure-response, modeling and simulation, and quantitative drug development. + A minimum of 20+ years of progressive pharmaceutical or biotechnology drug development experience, including substantial leadership experience in Clinical Pharmacology and/or Pharmacometrics, is expected. Extensive experience in oncology drug development, including Phase 1 and early clinical development, phase 2 and registrational trials, is strongly preferred.

• Other requirements:
• + Lead clinical pharmacology activities consistent with GCP, GLP, ICH, FDA, EMA, PMDA, and other applicable international regulatory requirements.

+ Apply appropriate scientific and regulatory judgment to clinical pharmacology and pharmacometric strategies. + Identify potential or actual program issues and initiate effective problem-solving to resolve or avoid them. + Evaluate new technologies and determine when they can provide meaningful advantages to oncology development. + Establish effective internal/external operating models and manage CRO and consultant relationships. + Communicate complex quantitative and scientific concepts clearly to senior leadership and cross-functional development teams. + Maintain appropriate scientific oversight and governance of AI-enabled analyses and ensure that AI-supported conclusions remain scientifically defensible and reproducible. + Maintain active engagement with the external scientific community through publications, presentations, collaborations, and scientific meetings.

• Travel Requirements:

• Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

• Mental/Physical Requirements:

• Fast-paced environment handling multiple demands is involved.

Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. The base salary range for this role is $270,300.00 - $337,900.00 Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

• Disclaimer:

• The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

• Confidential Data:

• All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

• Compliance:

• Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

• Drug Screening Requirements
• Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.
• Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
• Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. 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. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. SMPA may use Artificial Intelligence ("AI") as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.

• Our•Mission•_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ •Our•Vision•_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_