Executive Director, Translational Medicine and Toxicology

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.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Executive Director Biological Development and Toxicology Assessment. This individual will work across two diverse product lines in the Regenerative Medicine and Oncology spaces, supporting the scientific positioning and rational for both areas.

Job Duties and Responsibilities

• Provide scientific guidance to Rethymic Development and Manufacturing teams aligned with overall program goals
• Review scientific rational for regenerative medicine CMC and clinical
• Review and edited technical development and scientific strategy documents for Rethymic
• Review critical PAS submission documents for Rethymic, providing critical insight and alignment with rational and regulatory expectations
• Engage with CROs for in vivo rodent studies and model generation
• Finalize ERA plan for nuvisertib: Confirm study scope, endpoints, and required test articles; align with Chemical, Manufacturing and Controls (CMC) timelines and supply
• Vendor & budget leadership: Convert the current discussions and quotes into an executable statement of work (SOW) and detailed budget; secure start dates.
• Operational coordination: Orchestrate cross‑functional inputs (CMC, tox, program management), and track milestones through GDPM/Oncology forums.
• Ensure ERA outputs meet internal risk‑management documentation expectations and are ready for downstream use to support NDA filing with EMA for nuvisertib

Key Core Competencies

• In depth understanding of thymus biology and immune system functions
• Critical reasoning and problem solving of complex scientific arguments that align with regulatory expectations
• Understand and direct ERA plans aligning with CMC expectations within the oncology space
• Work with a highly diverse team of scientists and engineers to develop and ensure scientific rational and operational rational are supportive of each other
• High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
• Work in a highly matrixed and cross functional environment where

creative and scientifically valid rational and arguments are required

Education and Experience

• PhD/DVM/MD in biochemistry, immunology, protein chemistry, molecular biology or related field of practice
• Experience in assay development for both nonclinical assessments as well as CMC requirements
• Experience in various aspects of toxicology assessments
• Direct experience with global regulatory bodies and expectations for various phases of development
• 15-20 years experience in biotechnology/biopharma/pharmaceutical industry

The base salary range for this role is $255,300 to $319,100. 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. The