Senior Principal Toxicologist
Hybrid WFH role, must be local or relocate
COMPANY OVERVIEW
We provide contract research services on innovative approaches to drug discovery and drug development for and with emerging pharmaceutical, biopharmaceutical, biotechnology companies, and the world’s leading drug development companies and medical research organizations. By assembling top-class scientists, state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas, We have a strong foundation to continue our unique leading position as a contemporary drug discovery and development company.
SITE OVERVIEW
The site comprises a comprehensive portfolio of tools and services to support clients through drug safety and disposition evaluations, such as lead optimization through drug candidate selection, in vivo toxicology and pharmacology, vaccine safety testing, and developmental and reproductive toxicology. The site is located in a major life science hub on the Mid-Atlantic East Coast, offering a vibrant scientific community. The site is comprised of just under 70 people. There is a small company feel of the site with the large company resources of the overall organization.
With respect to Study Directors and Toxicologists, there is an equal split between General Toxicology studies and Developmental and Reproductive Toxicology (DART) studies. Related to career development we encourage and provide resources for our Toxicologists and Study Directors to become Diplomates of the American Board of Toxicology (DABT) and attend relevant industry conferences.
POSITION SUMMARY
To support our continued growth, we are seeking a career-minded professional scientist to join our team as Senior Principal Toxicologist within our Gaithersburg, Maryland site. In this role, the Senior Principal Toxicologist will report to the Sr. Director of Developmental and Reproductive Toxicology and, working closely with the Sr. Director, Developmental and Reproductive Toxicology will be responsible for maintaining the high level of professional and scientific standards of Study Directors, in support of the toxicology center of excellence culture.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Overall responsibility for training Study Directors in documentation standards (GLP), technical problem solving, technical communication with clients, and regulatory expectations of Study Directors.
o Includes training and mentoring of other Study Directors in the principles and processes.
• Perform Study Director responsibilities for assigned studies:
o Experience in toxicology evaluation across multiple species.
o Prepare study protocols/amendments and assure that protocols and changes are followed.
o Review and approve all study activities, including animal orders, formulation procedures, randomization, data collection, and timeframes.
o Observe animals throughout the study cycle.
o Review study data for scientific quality, animal welfare, and protocol compliance.
o Address unforeseen circumstances and that appropriate corrective actions are taken and documented.
o Accurately apply study director hours to client proposals.
o Respond to Quality Assurance audits.
o Interpret study data and prepare final reports for internal and external clients.
o Regularly communicate with Study Sponsors.
o 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.
PROFESSIONAL QUALIFICATIONS:
Education/Experience:
• 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.
Skills, Specialized Knowledge, and Abilities:
• 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.
PROFESSIONAL RESPONSIBILITIES: (if applicable)
• 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, 401K participation with company match, etc.
