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Parabilis Medicines, a clinical-stage biopharmaceutical company, is seeking an Associate Director of Toxicology to lead nonclinical safety programs across its pipeline of Helicon™-based therapeutics. The company is pioneering alpha-helical peptides to modulate intracellular proteins previously considered undruggable, with lead candidate zolucatetide in clinical development for Wnt/β-catenin-driven diseases including desmoid tumors and familial adenomatous polyposis.
This is a hands-on scientific leadership role embedded in discovery and early development, with accountability for advancing candidates from lead optimization through IND filing and clinical development. The successful candidate will serve as the nonclinical safety lead on cross-functional project teams, working autonomously to define strategy, drive execution, influence candidate selection, and ensure robust safety assessment.
Key responsibilities include: partnering with discovery teams during pre-lead optimization and lead optimization phases to identify safety liabilities and guide candidate selection; serving as primary toxicology lead on project teams, developing candidate-specific risk assessments and go/no-go recommendations; applying expertise in injectable formulations (subcutaneous, intravenous, intramuscular) to address local tolerance and route-specific safety considerations; designing and overseeing complete IND-enabling nonclinical safety packages including acute/repeat-dose toxicology, safety pharmacology, genotoxicity, and local tolerance studies; selecting appropriate species, routes, doses, and study durations based on scientific rationale and regulatory expectations; authoring nonclinical sections of INDs and CTAs; and maintaining awareness of FDA, EMA, and ICH guidance.
The role includes CRO management and study execution responsibilities: selecting and managing contract research organizations for GLP and non-GLP studies; reviewing protocols, amendments, and final reports for scientific rigor and GLP compliance; monitoring study progress and making real-time scientific decisions; and overseeing test article logistics and formulation preparation in coordination with CMC and Pharmaceutical Sciences teams.
The candidate will also contribute to scientific leadership, mentoring junior toxicologists, and collaborating with regulatory, clinical, and research functions to ensure integrated program advancement.
