ToxStrategies, Inc., is seeking an experienced toxicologist/pharmacologist (10+ years biopharmaceutical/pharmaceutical experience, in consulting and/or industry, government [e.g., FDA] or Contract Research Organizations [CROs]), to join our expanding Biopharmaceutical/Pharmaceutical consulting practice. ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. Scientists in our Biopharmaceutical/Pharmaceutical Practice provide consulting services to companies in all phases of the drug development process. This includes providing clients with scientific, strategic, and regulatory expertise in the nonclinical safety assessment of biopharmaceutical/ pharmaceutical products. This position requires an in-depth understanding of the scientific and regulatory process for the development of biopharmaceutical/pharmaceutical products for a variety of therapeutic indications. The candidate must be familiar with current ICH and regulatory agency guidelines for drug development, industry trends, as well as new endpoints and methods used in safety assessment studies.
This position will 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 nonclinical sections of 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, 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 and design, data interpretation, and monitoring of toxicology studies
- Interpret safety, TK/PK, and PK/PD data
- Serve as the toxicology representative on project teams
- Participate in meetings with FDA and international 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.
- 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
- Travel may be required (up to approximately 20%)
- Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is desired but not required
- Prior pharmaceutical consulting and/or biopharmaceutical/pharmaceutical industry and/or government experience (FDA) required (minimum 10+ years)
- Prior demonstrated experience in the development of biotechnology-derived drug products, cellular and/or gene therapy products, anti-viral therapies and vaccines, or ophthalmology products is highly desired but not required
- 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 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 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 firstname.lastname@example.org.