Sumitomo Pharma America, Inc.
We are united in our mission to deliver patient-needed therapies sooner.
Executive Director – Translational Medicine, Toxicology
Location
United States
Posted
6 days ago
Salary
$255.3K - $319.1K / year
Postgraduate Degree15 yrs expEnglish
Job Description
• Provide scientific guidance to Rethymic Development and Manufacturing teams aligned with overall program goals
• Review scientific rationale for regenerative medicine CMC and clinical
• Review and edit technical development and scientific strategy documents for Rethymic
• Review critical PAS submission documents for Rethymic, providing critical insight and alignment with rationale 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
Job Requirements
- PhD/DVM/MD in biochemistry, immunology, protein chemistry, molecular biology or related field of practice
- 15-20 years experience in biotechnology/biopharma/pharmaceutical industry
- 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
Benefits
- eligibility for our 401(k) plan
- medical, dental, vision, life and disability insurances
- leaves provided in line with your work state
- 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
