Associate Director, Toxicology

Latigo Biotherapeutics, Inc.; San Francisco (CA); Sur place; USD 130 000 - 170 000; Plein temps

Résumé du poste

Latigo Biotherapeutics, Inc. is seeking an experienced Associate Director of Toxicology in San Francisco, California. This role involves designing, overseeing, and interpreting nonclinical safety strategies essential for pipeline progression.

The ideal candidate will have a PhD in Toxicology or a related field, alongside 10+ years in the nonclinical safety domain, supporting regulatory strategies and providing scientific insights to cross-functional teams.

Qualifications

• 10+ years of industry experience in nonclinical safety/toxicology.
• Experience with IND-enabling and regulatory toxicology strategies.
• DABT board certification is preferred.

Responsabilités

• Design and oversee nonclinical safety studies, including toxicology studies.
• Analyze and interpret data to support program decisions.
• Author and review nonclinical sections of regulatory documents.

Connaissances

Scientific judgment

Communication

Problem-solving

Collaborative mindset

Attention to detail

Formation

PhD in Toxicology, Pharmacology, or related discipline

Outils

Knowledge of GLP regulations

Experience with CRO management

Description du poste

We are seeking a highly motivated and experienced Associate Director of Toxicology (Nonclinical Safety) to support the advancement of our pipeline programs. This individual will play a key role in designing, executing, and interpreting nonclinical safety strategies across discovery and development programs. This role will contribute to research and development programs.

The successful candidate will serve as a subject matter expert on cross‑functional teams and contribute to regulatory strategy, ensuring that nonclinical programs are scientifically robust and aligned with development timelines.

Key Responsibilities

Nonclinical Strategy & Leadership

• Serve as the nonclinical safety/toxicology subject matter expert on multidisciplinary project teams
• Provide integrated assessments of nonclinical data and evaluate overall risk/benefit profiles
• Contribute to development candidate selection and overall program strategy

Study Design & Execution

• Design, oversee, and monitor nonclinical safety studies, including:
  • Exploratory/non‑GLP toxicology studies
  • IND‑enabling toxicology and safety pharmacology studies
  • Post‑IND studies (e.g., sub‑chronic, chronic, reproductive, carcinogenicity)
• Manage and oversee CROs and external vendors, including study design, execution, and data quality

Data Analysis & Interpretation

• Analyze and interpret nonclinical study data to support program decisions
• Prepare and present findings, and provide guidance to internal stakeholders and governance teams
• Identify data gaps and proactively develop mitigation strategies

Regulatory Support

• Author and review nonclinical sections of regulatory documents, including:
  • INDs
  • Investigator’s Brochures (IBs)
  • Briefing books and responses to health authorities
• Partner with Regulatory Affairs to support interactions with agencies (e.g., FDA)
• Ensure compliance with GLP, ICH, and applicable regulatory guidelines

Cross‑Functional Collaboration

• Work closely with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams
• Contribute to integrated development plans and timelines
• Support portfolio‑level decision‑making through scientific insight

Qualifications

Education & Experience

• PhD in Toxicology, Pharmacology, or related scientific discipline
• DABT board certification is preferred
• ~10+ years of industry experience in nonclinical safety/toxicology
• Experience supporting small molecule drug development programs preferred
• Experience with IND‑enabling and regulatory toxicology strategies required

Core Competencies

• Strong scientific judgment and problem‑solving capabilities
• Excellent communication and presentation skills
• Ability to work effectively in cross‑functional, fast‑paced environments
• Collaborative, proactive, and detail‑oriented mindset

Technical Skills

• Strong knowledge of GLP regulations, ICH guidance, and regulatory expectations
• Experience designing, monitoring, and interpreting nonclinical safety studies
• Familiarity with CRO oversight and external vendor management

Preferred Qualifications

• Experience supporting regulatory submissions and agency interactions
• Background in pain, neuroscience, or related therapeutic areas
• Prior experience in early‑stage biotech environments