Associate Director, Toxicology

The role

The Associate Director, Toxicology will lead nonclinical safety programs across a diverse pipeline. This role involves advancing candidates from lead optimization through IND filing and serving as the nonclinical safety lead on cross-functional project teams.

What you will do

• Partner with discovery teams to identify safety liabilities and guide candidate selection.
• Serve as the primary toxicology lead on project teams to ensure IND readiness.
• Develop and communicate candidate-specific toxicology risk assessments.
• Apply knowledge of injectable formulations to address safety considerations.
• Design and oversee the complete IND-enabling nonclinical safety package.
• Select appropriate species, routes of administration, doses, and study durations.
• Author and own nonclinical sections of INDs and CTAs and support regulatory interactions.
• Select and manage CROs and specialty contract laboratories.
• Review study protocols, amendments, and final reports.
• Monitor study progress and interpret interim data.

Required qualifications

• DVM or PhD in Toxicology, Pathology, Pharmacology, or a closely related discipline
• 8+ years of industry experience in drug development
• Hands-on experience leading nonclinical safety programs from early discovery through IND filing
• Experience supporting multiple modalities, including small molecules and at least one of: siRNA/oligonucleotides, therapeutic peptides, PROTAC degraders, ADCs, or mRNA
• Experience with injectable drug products (IV, SC, and/or IM)
• Familiarity with local tolerance study design and excipient/formulation safety assessment
• Ability to function as an independent scientific leader on project teams
• Strong working knowledge of relevant ICH guidelines (M3(R2), S6(R1), S7A/B, S8, S9)
• Knowledge of GLP regulations (21 CFR Part 58) and FDA/EMA regulatory expectations
• Demonstrated CRO management experience across GLP and non-GLP studies
• Excellent written and verbal communication skills
• Ability to work on-site and attend in person meetings

Nice to have

• DABT certification
• Familiarity with in vitro NAM-based safety tools (e.g., microphysiological systems, iPSC-derived models, QSAR/in silico platforms)
• Experience contributing to regulatory agency meetings
• Experience responding to nonclinical IND-related queries
• Experience supporting due diligence and in-licensing evaluations

Benefits

• Annual target bonus
• Equity
• Comprehensive suite of competitive benefits

About the company

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating medicines for patients with serious diseases by unlocking biologically important targets. The company has pioneered a new class of alpha-helical peptides called Helicons™.