Toxicology Positions

Our client is a large US based drug company with a broad portfolio of approved and development stage assets. They are seeking an experienced Project Toxicologist to join their growing toxicology group (Reporting to an Executive Director).

They seek a strong scientific background (doctoral degree required) and four to ten years of pharma industry experience in strategic project toxicology work. The duties include active participation on development project teams, data evaluation and regulatory report writing, and engagement with the company’s toxicology operations team for external studies.

The role will support a broad spectrum of modalities which target multiple disease targets, so previous breadth of experience is desired. The company is remote embracing, with the ability to hire this person in either the U.S. or Europe.

Our client is seeking an experienced Toxicology Operations specialist to support the planning, coordination, execution, and oversight of nonclinical toxicology studies that advance drug development programs from early research through regulatory submission and lifecycle support. This individual will work closely with cross-functional teams and external research partners to ensure studies are executed with scientific rigor, regulatory compliance, and operational excellence.

The successful candidate will serve as a key liaison between internal stakeholders and contract research organizations (CROs), helping manage study execution, timelines, data review, and reporting while contributing to continuous process improvement across the toxicology function.

Scientific Responsibilities

• Coordinate communications with CRO study directors, principal investigators, and scientific staff throughout the lifecycle of toxicology studies.

• Review study protocols, amendments, deviations, draft reports, and supporting documentation for scientific quality, completeness, and consistency.

• Compile, organize, and evaluate toxicology data to identify trends, discrepancies, or findings requiring further scientific assessment.

• Prepare data summaries, figures, tables, and presentations for project team meetings and governance reviews.

• Support preparation of toxicology content for regulatory submissions, including Investigator’s Brochures, INDs, CTDs, annual reports, marketing applications, and responses to regulatory agencies.

• Assist with investigative studies that evaluate unexpected toxicological findings, mechanisms of toxicity, species differences, or other scientific questions. • Contribute scientific input during project team discussions related to study design, interpretation, and development strategy.

Operational Responsibilities

• Coordinate GLP and non-GLP toxicology studies conducted at external CROs.

• Manage study startup activities including requests for proposals, timelines, protocol development, test article logistics, and study scheduling.

• Monitor study milestones, budgets, deliverables, and action items to ensure projects remain on schedule.

• Coordinate shipment and tracking of study materials, formulations, biological samples, and related documentation.

• Serve as a communication hub among toxicology, pathology, bioanalysis, DMPK, quality, regulatory affairs, CMC, project management, finance, and external vendors.

• Maintain study tracking systems, electronic files, databases, and documentation to support inspection readiness.

• Participate in improving operational workflows, study management tools, templates, and best practices within the toxicology organization.

Qualifications

• Bachelor’s or Master’s degree in Toxicology, Pharmacology, Biology, Veterinary Science, Life Sciences, or a related scientific discipline.

• Eight or more years of experience supporting nonclinical toxicology within the pharmaceutical, biotechnology, or CRO environment.

• Demonstrated experience coordinating outsourced nonclinical toxicology studies.

• Working knowledge of Good Laboratory Practice (GLP) regulations and the nonclinical drug development process.

• Strong organizational and project management skills with the ability to manage multiple concurrent studies.

• Excellent written and verbal communication skills with experience collaborating across multidisciplinary teams.

• Proficiency with Microsoft Office applications; experience using project management platforms, scientific databases, electronic document management systems, or data visualization software is advantageous.

Preferred Qualifications

• Experience supporting multiple therapeutic areas or drug modalities.

• Familiarity with regulatory documentation and global health authority submissions.

Our client is a small pharmaceutical company, which is very closely tied to a life sciences venture capital firm. In the last few years, this company has launched five spinoffs which have drug candidates in clinical phase development.

The company is evolving from the use of toxicology consultants; and has entrusted us to identify their first Toxicology Leader (AD, Director or Senior Director level). Qualified candidates will have an advanced degree, five or more years of experience and deep knowledge of large molecule safety assessment. The company primarily develops therapeutics for immunology and inflammation targets.

The person hired for this role will need to be willing to perform all the common tasks of a pharmaceutical toxicologist (project team participation, CRO selection and study design/management and interactions with the FDA and peer regulatory agencies), with no initial supervision. The role is US remote embraced and reports to the company’s VP Translational Research/Preclinical Sciences.