Senior Toxicology Scientist & Project Leader – Pharma

BlueRidge Life Sciences; Athens (GA); Presencial; USD 160.000 - 260.000; Jornada completa

Descripción de la vacante

BlueRidge Life Sciences, through its ToxStrategies division, seeks an experienced toxicologist with 15+ years in biopharmaceuticals or consulting to lead nonclinical safety programs and regulatory interactions. You will design studies, interpret complex data, and contribute to regulatory submissions with seasoned leadership in safety assessment.

You will work with cross-functional teams, interact with regulators (FDA, MHRA, EMA), and guide projects from pre-IND through NDA/BLA.

Formación

• Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is desired but not required.
• Prior pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA) required (minimum 15+ years)
• Comprehensive understanding of ICH and regulatory agency guidance documents for nonclinical drug development
• Experience overseeing nonclinical safety assessment programs through all development phases (e.g., pre-IND to marketing)
• Experience writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs) and interacting with regulatory agencies
• Experience managing and resolving project-related toxicology and/or clinical-hold issues
• Project management experience balancing complex, high-priority programs and timelines
• Demonstrated written and verbal communication skills
• Ability to work independently or in multidisciplinary teams
• Member of and actively involved in scientific/toxicology professional organizations (e.g., BioSafe, SOT, ACT)

Responsabilidades

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical development
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies
• Serve as the toxicology representative on project teams
• Participate in meetings with global regulatory authorities
• Write/regulate nonclinical sections of regulatory submissions (pre-IND, IND/CTA, NDA/BLA)
• Contribute to expert opinions, waiver requests, proposals, and presentations
• Participate in due diligence for in- and out-licensing; travel up to ~20%

Educación

Ph.D. in toxicology or related sciences

Descripción del empleo

BlueRidge Life Sciences, through its ToxStrategies division, seeks an experienced toxicologist with 15+ years in biopharmaceuticals or consulting to lead nonclinical safety programs and regulatory interactions. You will design studies, interpret complex data, and contribute to regulatory submissions with seasoned leadership in safety assessment.

You will work with cross-functional teams, interact with regulators (FDA, MHRA, EMA), and guide projects from pre-IND through NDA/BLA.