This position may involve designing and overseeing nonclinical safety assessment programs for drug candidates and interpreting and integrating data across studies for clients and regulatory authorities. Additional responsibilities may include overseeing development of study protocols and reports, writing nonclinical sections of regulatory documents (e.g., pre-IND packages, IND/CTAs, BLAs/NDAs, Investigator Brochures), and interacting with regulatory agencies (e.g., FDA, MHRA, EMA). Within ToxStrategies, you will work alongside toxicologists, epidemiologists, engineers, and biostatisticians who are recognized as leaders in their respective fields. This position offers a stimulating and challenging work environment, opportunities for professional development and leadership, and competitive compensation and benefits.
Responsibilities May Include:
- 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%)
Essential Qualifications:
- 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
For more information about ToxStrategies, please visit www.toxstrategies.com. To apply, please submit a cover letter and resume to hr2@toxstrategies.com.