ToxStrategies, Inc., is seeking an experienced toxicologist/pharmacologist (minimum of 3 years industry or Contract Research Organizations [CRO] experience), to join our expanding team as a Toxicology Study Monitor. ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. This position would provide study monitoring support to consultants with clients in a variety of industries, including the biopharmaceutical/pharmaceutical and food technology spaces. This position requires an in-depth understanding of the scientific and regulatory requirements for in vitro and in vivo toxicology studies, including familiarity with current ICH, OECD, and regulatory guidelines for study designs, as well as industry trends and new techniques and methods used in safety assessment studies.
The person who fills this position will design and oversee nonclinical safety assessment studies with guidance from senior ToxStrategies consultants, develop study protocols and reports, and interpret data and review reports from various studies for the client. The candidate may also assist in other aspects of practice responsibilities, including document quality control (QC) review, and 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:
- Facilitate CRO selection and study placement and provide leadership in the design, oversight, and monitoring of contracted toxicology studies, including general, reproductive, or genetic toxicology studies or carcinogenicity studies
- Review study-related documents, including SOWs, protocols, and reports, for completeness, accuracy, and consistency
- Schedule, track, and monitor study timelines, progress, and milestones, such as peer reviews and corresponding subreports and main reports from CROs
- Ensure timely finalization of study reports and SEND packages to support regulatory submissions
- Participate on study-related issue-resolution teams through active engagement in scientific discussions and development of strategies designed to support and inform critical development decisions
- Assist in interpreting data, such as safety, TK/PK, and PK/PD
- Establish and maintain excellent working relationships with new and existing CROs
- Perform and document CRO site visits to monitor study progress, conduct, and compliance with SOPs and regulatory guidance
- Travel may be required (e.g., on-site study monitoring of critical study activities; up to approximately 50%)
- BS, MS, or Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is highly desired but not required
- Minimum of 3 years of experience in the biopharmaceutical/pharmaceutical industry, government (FDA), and/or CROs
- Experience as a Study Director, Toxicologist, or Study Monitor (or Sponsor Representative) conducting/overseeing in vivo toxicology studies is required
- Experience working with safety assessment teams is desired
- Experience in genetic and/or reproductive and developmental toxicology studies is highly desired
- Experience with a variety of molecules (including small molecules, biologics, botanicals, cell and gene therapies, UVCBs, etc.) is desired
- Should be familiar with ICH, OECD, and regional regulatory guidance documents for nonclinical safety assessments
- Knowledge of major species typically evaluated as toxicology models
- Project management experience and attention to detail
- Strong organizational skills and ability to manage multiple assignments
- Strong written and verbal communication skills and the ability to negotiate and influence decision-making processes and manage issues to resolution
- A pro-active and flexible attitude, sense of urgency (capable of making fast, informed decisions, when necessary)
- Ability to work independently or in multidisciplinary teams
ToxStrategies does not provide sponsorship for employment visa status.
ToxStrategies is an Equal Opportunity Employer and a Woman-Owned Business.