ToxStrategies, Inc., is seeking an experienced toxicologist/pharmacologist (minimum of 5 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 pharmaceutical 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 understanding 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 guidelines for drug development, as well as industry trends and new techniques and methods used in safety assessment studies.
This position will involve designing and overseeing nonclinical safety assessment programs for drug candidates, developing study protocols and reports, and interpreting data from various studies for the client and regulatory authorities. The candidate may also be responsible for writing nonclinical sections of regulatory documents (e.g., pre-IND packages, INDs/CTAs, BLAs/NDAs, Investigator Brochures), as well as risk assessments/monographs (e.g., excipients, impurities/degradants, solvents, leachables/extractables). 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:
- 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
- Write pharmacology/toxicology sections of regulatory submission documents (e.g., pre-IND, IND, NDA/BLA)
- Prepare toxicology risk assessments/monographs for drug product excipients, impurities, solvents, or leachables/extractables
- Write 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 journal papers and book chapters
- Travel may be required (e.g., on-site study monitoring; up to approximately 20%)
- BS, MS, or Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is highly desired but not required
- Minimum of 5 years of experience in the biopharmaceutical/pharmaceutical industry, government (FDA), and/or Contract Research Organizations (CROs) (postdoctoral work is not applicable to the required 3 years)
- Familiar with ICH and regional regulatory guidance documents for nonclinical drug development
- Experience working with drug development teams
- Project management experience and attention to detail
- Strong organizational skills and ability to manage multiple assignments
- Excellent 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 publications
ToxStrategies is an Equal Opportunity Employer.