Job Description

ToxStrategies, Inc., is seeking an experienced toxicologist/pharmacologist (minimum of 7–10 years experience in in biopharmaceutical/pharmaceutical consulting and/or industry or government [e.g., FDA]) 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 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 guidelines for drug development, as well as industry trends and new endpoints and methods being used in safety assessment.

This position will involve designing and overseeing (monitoring) 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 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 pharmaceutical/biopharmaceutical 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:

• MS or Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is highly desired but not required
• Prior pharmaceutical consulting and/or biopharmaceutical/pharmaceutical industry and/or government experience (FDA) required (minimum 7–10 years)
• Comprehensive understanding of ICH and regional regulatory guidance documents for toxicology studies of drug products
• Experience working with drug development teams (may require educating inexperienced teams on the purpose of toxicology testing)
  • Experience overseeing the entire nonclinical safety assessment program for drug candidates through all drug 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 project-related and toxicology and/or clinical-hold issues, and ability to resolve situations and develop strategic options
• Project management experience
• 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 on ToxStrategies’ practice areas and team, please visit www.toxstrategies.com. To apply, please submit a cover letter and resume to hr@toxstrategies.com.

ToxStrategies is an Equal Opportunity Employer and a Woman-Owned Business.