Executive Director – Translational Medicine, Toxicology
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $255,300 - $319,100 per year
Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
assay developmenttoxicology assessmentsregenerative medicineCMC (Chemical, Manufacturing and Controls)NDA filingin vivo studiesmodel generationrisk management documentationscientific strategy documentstechnical development
Soft Skills
scientific guidancevendor leadershipbudget managementoperational coordinationcross-functional collaborationmilestone trackingcritical insightcommunicationorganizational skillsleadership
Certifications
PhDDVMMD