Director, Nonclinical Development - Toxicology

Scorpion Therapeutics; Boston (MA); Hybrid; USD 250,000 - 360,000; Full time

Job summary

Scorpion Therapeutics in Boston, MA seeks an accomplished Director of Nonclinical Development, Toxicology, to lead safety programs from discovery through late-stage development and regulatory submissions.

You will drive GLP/non-GLP studies, guide CROs, and collaborate with cross-functional teams to ensure alignment with global regulatory expectations.

Strong leadership, communication, and deep expertise in toxicology and ICH regulations are essential.

Qualifications

• PhD in Toxicology, Pharmacology, or related field with senior leadership experience.
• 10+ years in industry with toxicology leadership and cross-functional influence.
• Experience advancing small molecule candidates from discovery to clinical development.

Responsibilities

• Oversee integrated safety strategies from IND enabling studies through Phase 2/3 and regulatory submissions.
• Serve as toxicology expert on cross-functional teams.
• Design and interpret GLP and non-GLP toxicology studies (including safety pharmacology, reproductive, juvenile, and carcinogenicity).
• Lead external CROs and manage relationships.
• Contribute to regulatory documents and agency interactions.
• Ensure alignment with global regulatory standards.

Skills

Toxicology leadership

Cross-functional leadership

CRO management

Regulatory knowledge

GLP studies

Scientific communication

Education

PhD in Toxicology

DVM or equivalent

Tools

ICH regulations

Job description

Role

Director of Nonclinical Development, Toxicology, providing strategic leadership and execution of nonclinical safety programs for small molecules and peptides across early to late-stage development.

Responsibilities

• oversee integrated safety strategies from IND-enabling studies through Phase 2/3 and regulatory submissions
• serve as toxicology expert on cross-functional teams
• design and interpret GLP and non-GLP toxicology studies (including safety pharmacology, reproductive, juvenile, and carcinogenicity)
• lead external CROs
• contribute to regulatory documents and agency interactions
• and ensure alignment with global regulatory standards.

Requirements

• PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field
• 10+ years in industry with significant toxicology leadership
• experience advancing small molecule candidates from discovery through clinical stages
• deep expertise in toxicology, safety pharmacology, DMPK principles, and ICH regulations
• proven ability to influence cross-functional teams and manage CRO relationships
• strong written/verbal communication skills.

Preferred

• experience supporting Phase 2/3 programs, NDA submissions, peptide therapeutics, juvenile toxicology models, and global regulatory interactions
• exposure to early-stage biotech environments.

High-Value

• small molecule and peptide therapeutics, IND-enabling to late-stage development, regulatory interactions with agencies such as FDA and EMA, and work in a hybrid Boston-based setting with some travel.