Senior Principal Toxicologist

Position Summary

To support our continued growth, we are seeking a career‑minded professional scientist to join our team as Senior Principal Toxicologist at the Gaithersburg, Maryland site. The Senior Principal Toxicologist will report to the Sr. Director of Developmental and Reproductive Toxicology and, working closely with that director, will maintain high professional and scientific standards for Study Directors within the toxicology center of excellence culture.

• Overall responsibility for training Study Directors in documentation standards (GLP), technical problem solving, technical communication with clients, and regulatory expectations of Study Directors.
  • Includes training and mentoring of other Study Directors in the principles and processes.
• Perform Study Director responsibilities for assigned studies:
  • Experience in toxicology evaluation across multiple species.
  • Prepare study protocols/amendments and assure that protocols and changes are followed.
  • Review and approve all study activities, including animal orders, formulation procedures, randomization, data collection, and time frames.
  • Observe animals throughout the study cycle.
  • Review study data for scientific quality, animal welfare, and protocol compliance.
  • Address unforeseen circumstances and ensure appropriate corrective actions are taken and documented.
  • Accurately apply study director hours to client proposals.
  • Respond to Quality Assurance audits.
  • Interpret study data and prepare final reports for internal and external clients.
  • Regularly communicate with Study Sponsors.
  • Host on‑site client visits and travel to client sites.
• Manages complex preclinical studies in accordance with established protocols, SOPs, GLPs, and other pertinent regulatory requirements.
• Reviews training of technical staff to ensure adequacy to perform study‑specific techniques.
• Assists business development in client discussions and study design.
• Reviews and develops new procedures, technologies, and SOPs as required.
• Serves as a professional resource to other departments.
• Accurately and effectively communicates with Operations, QA, and Business Development personnel.
• Prepares manuscripts and/or presents at scientific meetings.
• Engages in face‑to‑face meetings with clients.
• Other duties as assigned.

• Ph.D. in Toxicology or related field with 5‑10 years of experience in pharmaceutical toxicology and a drug discovery & development CRO; DABT certification preferred.
• Significant relevant experience for individuals with MS or BS could be considered in some circumstances.
• Knowledge of the drug development process and regulatory requirements.
• Demonstrated client interaction skills.
• Knowledge of vaccine safety is a plus.

• Leadership acumen with solid influencing skills necessary to drive change effectively and cross‑functionally.
• Demonstrated expertise in pharmaceutical toxicology best practices and processes.
• Understanding of GLP regulations; ability to apply practices daily and mentor when appropriate.
• Excellent written and verbal communication skills (English required); open, interactive style that facilitates high levels of trust.
• Consulting, and relationship development aptitude, capable of promoting and educating clients on services that meet their needs and/or challenges.
• Able and willing to guide more junior level scientists in the principles and practices of Study Director responsibilities as described in the various GLP guidance documents.
• Ability to multi‑task and participate in multiple preclinical research studies concurrently.
• Exceptional partnering and collaboration skills with stakeholders at all levels including clients and regulatory personnel.
• Self‑starter, capable of working independently to generate desired results.

• Attends continuing education courses, as appropriate.
• Maintain active involvement in professional organizations.
• Be knowledgeable in regulatory requirements.
• ACT, SOT, ATS membership a plus, if not we will encourage it in the future and provide resources.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short‑ and long‑term disability, paid time off, 401(k) participation with company match, and more.