Responsibilities May Include:
- Oversee the study design, data interpretation, and monitoring of toxicology studies, and interpret and incorporate safety, TK/PK, and PK/PD data, and anti-drug antibody responses
- 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
- Balance the demands of multiple complex, high-priority programs, and work under stringent timelines
- Participate in meetings with FDA and international regulatory authorities such as EMA
- Address scientific, regulatory, and business challenges associated with development of drug and biologic products
- Provide comments and develop positions on draft guidance issued by regulatory authorities worldwide
- 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)
- Prior demonstrated experience in the development of biotechnology-derived drug products, cellular and/or gene therapy products, or anti-viral therapies and vaccines is highly desired
- Comprehensive understanding of ICH and regulatory agency guidance documents for toxicology studies of drug products
- Experience working with drug development teams and overseeing the entire nonclinical safety assessment program for drug candidates through all drug development phases (e.g., pre-clinical to marketing)
- Experience performing gap analyses for drug development programs and identifying studies that are necessary to support clinical development
- Experience in writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs), and presenting to and interacting with regulatory agencies
- Experience managing project-related and toxicology and/or clinical-hold issues, and ability to resolve situations and develop strategic options
- 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.