Global CRO seeks a toxicologist to lead pre-clinical toxicology studies for key pharmaceutical and research clients. The toxicologist will be managing client relationships and studies from concept through interpretation to delivery of study results. All candidates should have expert level experience in drug discovery toxicology. The Toxicologist should be highly motivated, detail orientated, well organized, and highly skilled. He or she should thrive on overcoming challenges, enjoy creating and maintaining positive team relationships and shares a passion for innovation and quality work. The toxicologist will help direct the design and management of pre-clinical toxicology studies and other safety studies as well as IND enabling activities.
We are seeking toxicologists with strong research background in leading toxicology studies who are career-driven, have strong leadership skills, and a depth of experience in working on collaborative research teams. We offer accelerated career growth potential, and excellent benefits. We have many opportunities and consider only the best candidates to join our highly talented toxicology research team.
typical roles and responsibilities for Toxicologist
Conduct product safety and health risk assessments on the range of products and components through all phases of IND development
Work on multi-functional teams and serve as primary toxicology liaison
Gather information and provide guidance to project teams regarding all testing standards
Provide strategic and hands-on management, ensuring toxicology studies are conducted in line with appropriate regulatory guidelines and standards, these include FDA, WHO, GLP, & ISO
Initiate and manage contracts in conjunction with finance group and coordinate activities with academic collaborators for preclinical development in the areas of toxicology, pharmacology, and pharmacokinetics
Lead or manage the design, monitoring and interpretation of In Vitro, In Vivo or pre-clinical safety studies conducted under Good Laboratory Practices (GLP)
Author or present relevant toxicology information in appropriate journals or at conferences
Provide input into safety-related statements and other documentation for use with the public and the media
Gather needed information and identify areas of improvement, and provide needed training
Participate on cross-departmental teams to contribute to the development or revision of departmental policies and procedures.
Requirements for Toxicologist
Ph.D in toxicology or related discipline
2+ years experience in toxicology evaluation of multiple species
D.A.B.T. certification or eligibility
CRO experience in toxicology
Experience managing study teams
5+ years experience with EPA guidelines
Working knowledge of drug development and vaccine safety
Published scientific papers preferred
Experience managing complex pre-clinical studies in accordance with pertinent regulatory requirements.
A record of accomplishment managing multiple pre-clinical studies concurrently.
Strong project management skills and experience managing complex timelines for clinical studies
Experience with clinical and nonclinical programs in biotechnology and pharmaceutical industries
Strong analytical skills including interpretation of biologics, vaccines including preclinical and clinical samples
Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies
Salary range for Toxicologist
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