Senior Director, Technology & Innovation

Scorpion Therapeutics; Massachusetts; On-site; USD 250,000 - 330,000; Full time

Job summary

Scorpion Therapeutics in Massachusetts is seeking a senior toxicology leader to design, oversee, and interpret nonclinical safety programs across GLP toxicology, reproductive toxicology, carcinogenicity, and safety pharmacology.

You will leverage pharmacokinetic data to justify dose selection, guide IND/CTD submissions, and collaborate with clinical development, DMPK, and discovery teams to shape toxicology strategy. Strong communication and regulatory writing skills are essential.

Qualifications

• PhD in toxicology with 10-14 years' experience overseeing toxicology programs and GLP studies.
• Strong understanding of global toxicology guidelines (ICH, FDA, EMA).
• Plan IND-enabling and late-stage nonclinical toxicity studies.
• Experience writing and presenting nonclinical safety data in CTD format.
• Excellent interpersonal, organizational, and communication skills.
• Strong collaboration experience in cross-functional, matrix teams.
• Demonstrated scientific excellence (publications/conferences).
• ABT certification preferred.

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 toxicology strategy.
• Draft toxicology sections of regulatory documents (e.g., IND, IB, IMPD, BLA, NDA).

Skills

GLP Toxicology

Nonclinical Safety

Regulatory Submissions

Cross-functional Collaboration

Data Interpretation

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 toxicology strategy.
• Draft toxicology sections of regulatory documents (e.g., IND, IB, IMPD, BLA, NDA).

Requirements:

• PhD in toxicology with 10-14 years' 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 studies.
• Plan and execute late-stage nonclinical toxicity studies.
• Strong ability to write and present nonclinical safety data in CTD format for regulatory submissions (e.g., IND, NDA, MAA).
• Excellent interpersonal, organizational, and communication skills.
• Strong collaboration experience in cross-functional, matrix teams.
• Demonstrated scientific excellence (publications and/or conference presentations).

Preferred Qualifications:

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