Senior Toxicology Strategy Lead

BlueRidge Life Sciences; Texas; Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

BlueRidge Life Sciences is seeking an experienced toxicologist to join the ToxStrategies division. The role involves leading nonclinical safety programs for biopharmaceutical products, writing regulatory documentation, and interfacing with agencies such as FDA, EMA, and MHRA. A Ph.D.

with 15+ years of experience in pharma consulting or industry is required. You will work with a multidisciplinary team of toxicologists, epidemiologists, engineers, and biostatisticians, contributing to study

Qualifications

• Ph.D. in toxicology, pharmacology, or related sciences; DABT certification is desired but not required
• Prior pharmaceutical consulting and/or pharmaceutical industry and/or government experience (minimum 15+ years)
• Comprehensive understanding of ICH and regulatory agency guidance for nonclinical drug development
• Experience overseeing nonclinical safety programs through all development stages (pre-IND to marketing)
• Experience writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs) and interacting with regulatory agencies
• Demonstrated ability to manage multiple assignments and lead projects in high-priority programs

Responsabilités

• Address scientific, regulatory, and business challenges in pharmaceutical/biopharmaceutical product 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 (FDA, MHRA, EMA)
• Write or oversee nonclinical sections of regulatory submission documents (pre-IND, IND/CTA, NDA/BLA)
• Develop expert opinion reports, waiver requests, presentations, proposals, etc.
• Participate in due diligence for in- and out-licensing
• Attend toxicology meetings and contribute to committees and publications
• Engage in business development to attract new projects/clients
• Travel up to ~20%

Connaissances

Scientific communication

Regulatory understanding

Project management

Nonclinical toxicology

Team leadership

Formation

Ph.D. in toxicology, pharmacology, or related sciences

Description du poste

BlueRidge Life Sciences is seeking an experienced toxicologist to join the ToxStrategies division. The role involves leading nonclinical safety programs for biopharmaceutical products, writing regulatory documentation, and interfacing with agencies such as FDA, EMA, and MHRA. A Ph.D.

with 15+ years of experience in pharma consulting or industry is required. You will work with a multidisciplinary team of toxicologists, epidemiologists, engineers, and biostatisticians, contributing to study