Associate Director, Nonclinical Program Development

BioSpace - Boston, MA

Hiring: Associate Director, Nonclinical Program Development Company: BioSpace Location: Boston, MA Job Posted Time: 2026-09-13 18:07:01 Employment Type: Hybrid About the job Required Skills: •The Associate Nonclinical Program Development Director will support the design, execution, interpretation, and integration of nonclinical safety strategies across Beeline's immunology and inflammation portfolio. This role is intended for a rigorously trained scientist with strong program management/operational skills who can help translate nonclinical safety (safety pharmacology, toxicology), PK/PD, biodistribution, and translational biomarker data into efficient development plans and submission-ready packages. •The individual will partner closely with Toxicology, Early Development, Translational Medicine, Clinical Development, Clinical Pharmacology, Regulatory, CMC, Quality, Clinical Operations, Program Management, and external CRO/vendor partners to ensure nonclinical studies are designed, executed, interpreted, and documented to support IND-enabling packages, first-in-human (FIH) readiness, clinical progression, and future global marketing submissions. This position is tailored for a leader with experience driving nonclinical and translational programs in immune-mediated diseases, managing CROs, supporting IND submissions, designing fit-for-purpose nonclinical safety packages, contributing to biomarker strategies, and operating effectively in a fast-moving biotech environment. •Work Arrangement & Location: •This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as •Tuesday and Wednesday •. Additional on-site days may be required based on business needs, team priorities, or leadership direction. •Essential Duties And Responsibilities •Support and help drive nonclinical toxicology strategy for assigned pipeline assets — contributing to integrated safety plans that include toxicology, toxicokinetics, safety pharmacology, immunotoxicology, reproductive/developmental toxicology, carcinogenicity considerations, and other modality-specific assessments required to support clinical development and regulatory filings. •Provide program management/operational leadership for nonclinical development activities — building and maintaining study plans, timelines, risk logs, decision trackers, vendor deliverables, and cross-functional action plans to ensure nonclinical workstreams remain aligned with program milestones, governance expectations, and regulatory submission timelines. Support organization of central repositories by guiding systematic arrangement nonclinical reports and data sets in a consistent manner across programs. •Oversee CRO and external partner execution — supporting CRO/vendor identification, selection, contracting input, study star Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!