Senior Director, Toxicology

Scorpion Therapeutics; Watertown (MA); On-site; USD 190,000 - 230,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior toxicology leader to design, oversee, and interpret nonclinical safety programs across all phases of drug development in Watertown, MA. You will ensure GLP study execution and integrate PK data to justify dosing strategies.

You will collaborate with clinical development, discovery, and program teams, draft CTD sections for IND/NDA submissions, and represent toxicology in cross-functional leadership discussions.

Qualifications

• PhD in toxicology with 10–14 years of experience overseeing toxicology programs.
• Strong understanding of global toxicology guidelines (ICH, FDA, EMA).
• Experience planning IND-enabling and late-stage nonclinical studies.
• Proven ability to write and present nonclinical safety data in CTD formats.

Responsibilities

• Design, oversee, and interpret nonclinical safety studies across all drug development phases.
• Use pharmacokinetic data to justify toxicology doses and clinical dose selection.
• Oversee budgets, timelines, and study monitoring; visit GLP testing sites.
• Partner with clinical development, discovery, and program teams; present data and strategy.
• Draft toxicology sections for regulatory documents (IND, IB, NDA, BLA).

Skills

Toxicology

GLP toxicology

IND-enabling studies

CTD format expertise

Cross-functional collaboration

Regulatory writing

Education

PhD in Toxicology

Job description

Responsibilities:

• Design, execute, and interpret nonclinical safety studies across all phases of drug development, including GLP toxicology, reproductive toxicology, carcinogenicity, and safety pharmacology.
• Use pharmacokinetic data to justify toxicology study doses and support selection of safe and effective clinical doses.
• Oversee budgets, timelines, and study monitoring; visit GLP testing sites to review facilities and capabilities.
• Partner with clinical development, technical operations, DMPK/clinical pharmacology, discovery, and program teams; present data interpretation and strategy.
• Draft toxicology sections for regulatory documents (e.g., IND, IB, IMPD, BLA, NDA).

Requirements:

• PhD in toxicology with 10–14 years of experience overseeing toxicology programs and conducting GLP toxicology studies in the pharmaceutical industry.
• Strong understanding of global toxicology guidelines (ICH, FDA, EMA).
• Plan and execute IND-enabling studies for first-in-human.
• Plan and execute late-stage nonclinical toxicity studies.
• Expertise writing and presenting nonclinical safety data in CTD formats for regulatory submissions (e.g., IND, NDA, MAA).
• Excellent interpersonal, organizational, and communication skills.
• Strong collaboration in cross-functional, matrix teams.
• Demonstrated scientific excellence in toxicology via publications and/or conference presentations.

Preferred Qualifications:

• Experience with both large and small molecule drug development.
• Experience in hematology and rare disease drug development.
• A.B.T certification.