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About the Role
ToxStrategies, a division of BlueRidge Life Sciences, is seeking an experienced toxicologist to join their Pharmaceutical toxicology consulting practice. This role involves providing scientific, strategic, and regulatory expertise in the nonclinical safety assessment of biopharmaceutical and pharmaceutical products, and requires an in-depth understanding of drug development processes and regulatory guidelines.
Responsibilities
- 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
Requirements
- 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 working with drug development teams and overseeing nonclinical safety assessment programs through all development phases (e.g., pre-IND to marketing)
- Experience performing nonclinical gap analyses for drug development programs
- Experience writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs), and interacting with regulatory agencies
- Experience managing and resolving project-related and toxicology and/or clinical-hold issues
- Project management experience, including the ability to manage multiple assignments and balance the demands of overseeing complex, high-priority programs and stringent 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), including recent presentations and/or publications
Skills
- Toxicology
- Pharmacology
- Regulatory Science
- Risk Assessment
- Epidemiology
- Biostatistics
- Engineering
- Clinical Research
- Health Economics
- Pharmaceutical Commercialization
- Environmental Consulting
- Drug Development
- Nonclinical Safety Assessment
- ICH Guidelines
- Regulatory Agency Guidelines
- Project Management
- Written Communication
- Verbal Communication
- Business Development
Work Type
- Full-time
Experience Level
- 15+ years biopharmaceutical/pharmaceutical experience
Education Level
- Ph.D. degree in toxicology, pharmacology, or related sciences
- DABT certification
Benefits
- Competitive compensation and benefits
About the Company
- BlueRidge Life Sciences offers integrated, comprehensive solutions that address complex technical, clinical development, and safety and regulatory challenges, leveraging deep scientific, medical, and regulatory expertise and real-world experience.
- BlueRidge Life Sciences is a growing family of companies providing a comprehensive suite of life sciences services, spanning toxicology, regulatory science, risk assessment, epidemiology, biostatistics, engineering, clinical research, health economics, pharmaceutical commercialization, and environmental consulting.
- ToxStrategies is a multidisciplinary consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients.
- Scientists in our Pharmaceutical Practice provide consulting services to companies in all phases of drug development.