Principal Scientist Toxicology

Description

As Principal Toxicologist, this role leads and manages nonclinical safety strategies across multiple drug development projects. The incumbent serves as the primary toxicology representative on interdisciplinary project teams, leads the Nonclinical Expert Team (NCET), and provides scientific leadership from early discovery through regulatory submission and marketing authorization. The role is responsible for the design, adequate budgeting, oversight, monitoring, interpretation, communication, and reporting of nonclinical safety studies conducted internally and externally in GLP and non-GLP environments.

Responsibilities and Accountabilities

·       Serve as the Toxicology representative on cross-functional project teams and act as NCET lead.

·       Act as the Nonclinical Development representative on Research Project teams.

·       Design, adequately budget, oversee, monitor, interpret, communicate, and report nonclinical safety studies conducted internally and externally in GLP and non-GLP environments.

·       Develop and implement toxicology strategies aligned with clinical development plans from early discovery through regulatory submission and marketing authorization.

·       Proactively identify and manage safety risks and liabilities early in development across therapeutic modalities.

·       Prepare toxicological risk assessments supporting drug development, manufacturing, and product quality.

·       Prepare and review nonclinical documents for regulatory submissions and interactions with health authorities.

·       Collaborate with internal stakeholders, including pharmacology, PK, clinical, regulatory, CMC, and Quality teams.

·       Present integrated safety assessments to senior management and at project milestone reviews.

• Maintain awareness of evolving toxicology guidelines, risk-assessment methodologies, scientific developments, and the competitive environment.

Education and Experience

Education

• PhD, DVM, MD, PharmD, or equivalent advanced degree in Toxicology, Pharmacology, Life Sciences, or a related field.
• Toxicology board certification (ERT, DABT, or equivalent) is preferred.

Experience

• At least 5 years of experience as a nonclinical toxicologist in the pharmaceutical, biotechnology, or CRO environment.
• Proven track record in nonclinical safety assessment, toxicology strategy, and regulatory submissions.
• Relevant experience in biopharmaceutical development, including proteins or monoclonal antibodies, and immunotoxicology.
• Additional experience with gene therapies, RNA-based therapies, or small molecules is advantageous.
• Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements.
• Scientific experience in one or more relevant therapeutic areas and across multiple modalities is highly desirable.

Competencies

·       Excellent scientific leadership, communication, analytical, and cross-functional collaboration skills.

·       Proven ability to work effectively both independently and within cross-functional, multicultural, and international teams.

·       Ability to develop scientifically sound toxicology strategies, manage risks, and communicate integrated safety assessments clearly.

·       Strong planning and organizational skills, with demonstrated ability to manage priorities and timelines.

·       Ability to work successfully in a matrix organization and engage internal and external expertise as needed.

·       Experience in scientific and regulatory writing and in presenting results to scientific, project, management, and regulatory audiences.

• Fluent in written and spoken English.