Associate Director, Nonclinical Program Development

About the role

Beeline Medicines is seeking an Associate Director to lead nonclinical program development for its immunology and inflammation pipeline. The role will design, execute, interpret and integrate safety strategies, translating toxicology, PK/PD and biomarker data into development plans and IND‑ready packages.

Key responsibilities

• Define and drive nonclinical toxicology strategy, including safety pharmacology, toxicokinetics, immunotoxicology, reproductive/developmental toxicology and carcinogenicity assessments.
• Provide program‑management leadership for all nonclinical studies, ensuring alignment with IND‑enabling timelines and first‑in‑human readiness.
• Partner with Toxicology, Early Development, Translational Medicine, Clinical Development, Regulatory, CMC, Quality, Clinical Operations and external CROs to design and document studies.
• Prepare submission‑ready safety packages, support IND filings and contribute to biomarker strategies.
• Manage CRO relationships, oversee data integration and ensure compliance with regulatory expectations.

Required profile

• PhD‑level scientist with extensive experience in nonclinical safety programs for immune‑mediated diseases.
• Proven program‑management and operational leadership in fast‑moving biotech environments.
• Track record of supporting IND submissions and coordinating multi‑disciplinary teams.
• Strong communication skills to interface with internal stakeholders and external partners.

Required skills

• Nonclinical toxicology
• Safety pharmacology
• Toxicokinetics
• PK/PD analysis
• Biodistribution studies
• Translational biomarker analysis
• IND submission preparation
• CRO management