11 days old

Toxicologist (Pre-clinical Advisor) - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an experienced individual to work as a **Toxicologist (Pre-clinical Advisor)** at the National Institutes of Health in Bethesda, Maryland.

**This is a long-term contract position which offers:**

+ Competitive compensation and comprehensive benefit package

+ Optional health, vision, and dental plans

+ Vacation leave as well as 10 paid federal holidays and 401K plan. Access to NIHs unparalleled resources and niche scientific initiatives

**TASKS/SERVICES. The contractor shall:**

+ Provide recommendations on optimal non-clinical strategies to advance candidate products to the clinic.

+ Work closely with cross-functional groups to formulate non-clinical proof of concept and toxicology testing strategies prior to the start of any IND-enabling activities to ensure that the studies are meeting the programs needs and are designed to fulfil regulatory requirements

+ Communicate regulatory information to multiple departments and ensuring that the information is interpreted correctly.

+ Successfully interact with other functional area experts in a project team environment to recommend the best course of preclinical development for a given program and explain those recommendations to VRC Leadership.

+ Facilitate communication and collaboration internally and/or externally (i.e. vendors/CRO) to ensure mutual clarity amongst multidisciplinary teams and accuracy and suitability of documents/reports for regulatory submission.

+ Maintain current knowledge of relevant domestic and international regulations, including proposed final rules and guidance documents.

+ Review and approve toxicology protocols and reviewing non-clinical protocols for completeness and compliance with FDA current Good Laboratory Practice (GLP) and applicable regulations.

+ Develop and integrate timelines for non-clinical activities with overall program timelines and VRC goals, in close coordination with Program Management, CMC, Clinical, Regulatory groups and other stakeholders.

+ Work together with Regulatory personnel and subject matter experts to author relevant sections of regulatory submission documents (pre-IND and IND) as well as the nonclinical section of Investigators Brochures.

+ Prepare and/or review all IND non-clinical reports, including toxicology reports from vendors/CRO for submission to the regulatory authorities.

+ Provide responses to regulatory agencies comments regarding non-clinical research or potential pre-IND and IND submission issues.

+ Collaborate with strategic planning group during contract negotiation to provide insight and guidance regarding scope of work pertaining to non-clinical/toxicology studies

+ Oversee CROs and other external resources and ensure quality results are delivered. This includes study design, protocol development, coordination of study materials, data interpretation, report review and approval.

+ Develop and maintain SOPs, in collaboration with relevant subject matter experts, for non-clinical/toxicology studies, including their review and approval processes.

**REQUIREMENTS. The contractor must have:**

+ Ph.D. in toxicology, biology/pharmacology, with at least 10 years related experience with vaccines and other biologics.

+ American Board of Toxicology (DABT) required.

+ Regulatory Affairs Certificate preferred.

+ Experience specifically supporting drug discovery research and development from a toxicology standpoint.

+ Experience in designing, conducting, monitoring and interpreting nonclinical toxicology/research studies.

+ Demonstrated success managing interactions with external CROs, consultants and other contract organizations is a plus.

+ Working knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience conducting and monitoring toxicology studies is critical.


When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you arent contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats next.

It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.

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

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.

**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: 2021-03-31 Expires: 2021-05-01

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Toxicologist (Pre-clinical Advisor) - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814

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