Scientific Director, Nonclinical Toxicology Job at Meet, Chicago, IL

bHdoUEk3akF2cUt1dGN6TVVTcndHYXBm
  • Meet
  • Chicago, IL

Job Description

Meet is partnered with a globally leading pharmaceutical company on a Scientific Director, Nonclinical Toxicology!

This role involves serving as the nonclinical safety representative for assigned molecules, overseeing the strategy and execution of nonclinical toxicology programs, collaborating with project leads, interpreting data, and authoring regulatory documents. This senior-level role requires scientific expertise in nonclinical safety assessment, knowledge of industry practices and regulatory guidelines, and a vision for innovation in the field.

Location : The position is ideally based in Lake County, IL, near Chicago, with an on-site requirement of at least three days per week. There is flexibility to be located in Northern or Southern California or Massachusetts locations.

Responsibilities :

  • Serve as a nonclinical safety subject matter expert on multi-disciplinary project teams.
  • Develop and communicate nonclinical safety strategies and plans for various drug modalities (e.g., small molecules, biologics, ADCs, cell and gene therapies) across therapeutic areas (e.g., oncology, neuroscience, immunology).
  • Conduct due diligence reviews to assess risks and recommend actions for partnerships or in-licensing.
  • Author and submit regulatory documents (e.g., IBs, INDs/CTAs, NDAs/BLAs) and engage with regulatory agencies globally.
  • Perform impurity, excipient, and metabolite risk assessments throughout the drug development lifecycle.
  • Mentor team members on drug development, focusing on nonclinical aspects.
  • Participate in industry consortia addressing nonclinical drug development topics.

Qualifications :

  • PhD or DVM required.
  • 10+ years of experience leading nonclinical safety programs in the pharmaceutical industry.
  • Proven experience authoring regulatory documents and addressing regulatory agency inquiries.
  • Expertise in a specific therapeutic area or modality (e.g., gene therapy) is a plus.
  • Knowledge of drug metabolism, pharmacokinetics, and safety considerations (e.g., MIST, drug-drug interactions, toxicokinetics, anti-drug antibodies) is beneficial.
  • Strong project/program management and leadership skills.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.

If you're interested in hearing more about this opportunity please apply or send your resume to [email protected]

Job Tags

3 days per week,

Similar Jobs

Clover R Management

Class A CDL Driver | local Job at Clover R Management

 ...BONUS- $1,000 $500 at first load and $500 at 30 days ~ Local account ~ Home daily ~ paid weekly ~$1,300- $1,500 weekly average ~1700 Miles per week Overview: ~ Company Driver ~ No touch Freight ~ Stop pay ~ Sign on Bonus ~ Paid... 

James J. Williams

CDL-A Tanker Driver - Earn $75,400-$117,000/Year + Great Benefits Job at James J. Williams

 ...Job Description James J. Williams is Now Hiring Tanker and Bulk Transport CDL-A Drivers!\nTanker and Bulk Transport CDL-A Drivers \nEarn $75,400 - $117,000 per Year - Full Benefits \n\n Now Hiring For: \n\n \n\t Experienced CDL-A tanker and bulk transport... 

Seven Star Education Consultancy

Private French Tutor (Part Time in Shunyi, Beijing) Job at Seven Star Education Consultancy

- Delivering French language lessons to Young Learners in groups of 2 - 8 students, ages 8 - 13. - Research and develop engaging curriculum and effective course content for learning French- Managing student behavior and deliver results in students academic- Engaging...

Essentia Health

Medical Laboratory Assistant Job at Essentia Health

 ...patients we are privileged to serve. The Medical Laboratory Assistant is responsible for performing tasks to support pre-analytical and...  .../CertificationQualifications: FTE: 0.6 Possible Remote/Hybrid Option: Shift Rotation: Eve/Night Rotation (United... 

Novax Recruitment Group

Senior Structural Steel Project Manager Job at Novax Recruitment Group

 ...Job Title: Senior Structural Steel Project Manager Location: Austin, TX Salary: $100,000 - $130,000 per year Industry: Structural Steel Our Client: Our client is a full-service, market-leading, AISC Certified Steel Fabricator and Advanced Steel Erector...