This position may involve designing and overseeing nonclinical safety assessment programs for drug candidates, as well as interpreting and integrating data from various studies for the client and regulatory authorities. Additional responsibilities will include overseeing development of study protocols and reports, and writing various regulatory documents (e.g., pre-IND packages, IND/CTAs, BLAs/NDAs, Investigator Brochures), as well as presenting to and interacting with regulatory agencies (e.g., FDA or 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:
- Oversee the study 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
- Write or oversee writing of the pharmacology/toxicology sections of pre-IND, IND/CTA, and NDA/BLA submissions
- Participate in meetings with global regulatory authorities
- Prepare study documents, including proposals, reports, and presentations
- 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 and clients
- Participate in due diligence meetings for in- and out-licensing
- Travel may be required (approximately 20% of the time)
Essential Qualifications:
- Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is highly desired but not required
- Prior pharmaceutical consulting and/or pharmaceutical industry and/or government experience (FDA) required (minimum 7+ years)
- Comprehensive understanding of ICH and regulatory agency guidance documents for nonclinical drug development
- Experience working with drug development teams and on nonclinical safety assessment programs for drug candidates through all drug development phases (e.g., pre-IND to marketing)
- Experience performing nonclinical gap analyses for drug development programs
- Experience in 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
- Ability to manage multiple assignments and balance the demands of overseeing complex, high-priority programs
- 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.