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Associate Director, Nonclinical Program Development

Beeline Medicines

Boston, Massachusetts, United StatesSenior$181k/yr
Sign in to applyVerified 1h ago
Location
Boston, Massachusetts, United States
Work model
On-Site
Level
Senior
Salary
$181k/yr
Posted
2h ago

About this role

About Beeline Medicines

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

Job Summary

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

Hybrid - 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 start-up, protocol review, study monitoring, issue

Listing verified 1h ago. Applications go through the company's official careers site.

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Associate Director, Nonclinical Program Development at Beeline Medicines, Boston, Massachusetts, United States | Yoinka