Executive Director, Toxicology

Scorpion Therapeutics; United States; On-site; USD 175,000 - 275,000; Full time

Benefits offered by this job

401(k)

Medical/dental/vision/life insurance

Generous PTO

Health & wellness

Job summary

Scorpion Therapeutics in the United States seeks a senior leader to oversee nonclinical safety across discovery through early clinical development. You will lead toxicology and safety pharmacology programs, define risk-based strategies, and act as the primary nonclinical representative in governance and regulatory discussions.

You will guide cross-functional teams, manage GLP and investigative studies, and drive regulatory submissions with FDA/EMA interactions.

Qualifications

• PhD in Toxicology, Pharmacology, Pathology, DVM, or related field; board certification preferred.
• 18+ years in pharmaceutical/biotech R&D with nonclinical and regulatory toxicology.
• Expertise in small-molecule programs (discovery through IND-enabling/early clinical).
• Strong knowledge of GLP guidelines.
• Experience leading/mentoring toxicology teams in matrix environments.
• Extensive global regulatory submission experience; experience engaging FDA/EMA.
• Strong ability to integrate complex datasets across toxicology, pathology, DMPK, and pharmacology; CRO oversight experience.
• Excellent communication and influencing skills.

Responsibilities

• Lead and mentor toxicology and technical/operational staff.
• Define and execute nonclinical safety strategies across discovery, preclinical, and clinical stages.
• Provide expert toxicology and safety pharmacology input to cross-functional teams.
• Lead integrated nonclinical sub-teams with cross-functional oversight (Toxicology, DMPK, Bioanalytical Sciences, Clinical Pharmacology).
• Serve as primary nonclinical representative on Program Development Teams and in internal governance/external forums, including regulatory interactions.
• Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology studies.
• Develop safety strategies for new targets, lead optimization, and platform technologies.
• Oversee internal and CRO toxicology/safety pharmacology studies; ensure scientific quality, compliance, and timely delivery.
• Author/critically review toxicology sections of regulatory documents (pre-IND/IND/IBs).
• Present data and risk assessments; support product defense and regulatory submissions.

Skills

Leadership

Mentoring

Cross-functional

Nonclinical toxicology

Regulatory interactions

GLP knowledge

Data integration

Education

PhD in Toxicology/Pharmacology/Pathology/DVM

Job description

Key Responsibilities

• Lead and mentor toxicology and technical/operational staff.
• Define and execute nonclinical safety strategies across discovery, preclinical, and clinical stages.
• Provide expert toxicology and safety pharmacology input to cross-functional teams.
• Lead integrated nonclinical sub-teams with cross-functional oversight (Toxicology, DMPK, Bioanalytical Sciences, Clinical Pharmacology).
• Serve as primary nonclinical representative on Program Development Teams and in internal governance/external forums, including regulatory interactions.
• Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology studies.
• Develop safety strategies for new targets, lead optimization, and platform technologies.
• Oversee internal and CRO toxicology/safety pharmacology studies; ensure scientific quality, compliance, and timely delivery.
• Author/critically review toxicology sections of regulatory documents (pre-IND/IND/IBs).
• Present data and risk assessments; support product defense and regulatory submissions.

Qualifications

• PhD in Toxicology, Pharmacology, Pathology, DVM, or related; board certification (e.g., DABT, ERT) preferred.
• 18+ years in pharmaceutical/biotech R&D with nonclinical and regulatory toxicology.
• Expertise in small-molecule programs (discovery through IND-enabling/early clinical).
• Strong knowledge of GLP guidelines.
• Experience leading/mentoring toxicology teams in matrix environments.
• Extensive global regulatory submission experience; experience engaging FDA/EMA.
• Strong ability to integrate complex datasets across toxicology, pathology, DMPK, and pharmacology; CRO oversight experience.
• Excellent communication and influencing skills.

Compensation & Benefits

• Base salary: $175,000–$275,000; discretionary annual bonus; 401(k), medical/dental/vision/life insurance, generous PTO, health & wellness.

Work Location & Role

• US-based with occasional travel; Full-Time, Exempt.