15 days old


Kelly Services
Gaithersburg, MD 20898
**Kelly Services is actively recruiting for a Senior Principal Toxicologist in Gaithersburg, MD. This is a Direct Hire Opportunity!**

The company provides contract research services (CRO) to pharmaceutical, drug development and medical research companies and supports clients through drug safety and disposition evaluations, such as lead optimization through candidate selection, in vivo toxicology and pharmacology, vaccine safety testing, and developmental and reproductive toxicology.

The Senior Principal Toxicologist will report into the Sr. Director of Developmental and Reproductive Toxicology and 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.


+ Overall responsibility for training Study Directors in documentation standards technical problem solving and technical communication with clients, and regulatory expectations of Study Directors.

+ Includes training and mentoring of other Study Directors in the principles and processes.

+ Perform 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 timeframes.

+ Observe animals throughout study cycle.

+ Review study data for scientific quality, animal welfare, and protocol compliance.

+ Address unforeseen circumstances and that 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.

+ 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 10+ years of experience in pharmaceutical toxicology and a drug discovery & development CRO; DABT certification preferred.

+ 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.

+ Excellent written and verbal communication skills (English required); open, interactive style that facilitates high levels of trust.

+ Business development/sales acumen, 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.

+ Proficiency with MS Office Suite products.

+ Attends continuing education courses, as appropriate.

+ Maintain an active involvement in professional organizations.

+ Be knowledgeable in regulatory requirements.

+ ACT, SOT, ATS membership a plus.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2022-05-06 Expires: 2022-06-20

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Kelly Services
Gaithersburg, MD 20898

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