Senior Toxicology Strategy Leader (Pharma Consulting)

BlueRidge Life Sciences; California City (CA); In loco; USD 190.000 - 270.000; Tempo pieno

Descrizione del lavoro

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to join the ToxStrategies division. The role focuses on nonclinical safety assessment, regulatory strategy, and client-facing consulting across drug development stages.

The candidate will design and oversee nonclinical programs, interpret cross-study data, draft regulatory sections, and interact with agencies to advance projects.

Competenze

• Ph.D. in toxicology, pharmacology, or related sciences.
• DABT certification is desired but not required.
• Minimum 15+ years of pharmaceutical consulting and/or pharmaceutical industry and/or government experience.

Mansioni

• Address scientific, regulatory, and business challenges associated with development of pharmaceutical/biopharmaceutical products.
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies, and interpret safety, TK/PK, and PK/PD data.
• Serve as the toxicology representative on project teams.
• Participate in meetings with global regulatory authorities.
• Write or oversee writing of the pharmacology/toxicology sections of regulatory submission documents (e.g., pre-IND, IND/CTA, and NDA/BLA).
• Write or oversee writing of expert opinion reports, waiver requests, presentations, proposals, etc.
• Participate in due diligence meetings for in- and out-licensing.
• Attend and present at toxicology meetings (e.g., ACT, SOT), serve on professional/scientific committees, and publish (papers, book chapters).
• Conduct business development activities to attract and develop new projects/clients.
• Travel may be required (up to approximately 20%).

Formazione

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

DABT certification (desired)

Descrizione del lavoro

BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years in biopharmaceutical/pharmaceutical settings) to join the ToxStrategies division. The role focuses on nonclinical safety assessment, regulatory strategy, and client-facing consulting across drug development stages.

The candidate will design and oversee nonclinical programs, interpret cross-study data, draft regulatory sections, and interact with agencies to advance projects.