Director of IT Strategy, Business Alignment
Marmon Holdings, Inc.
Director, Toxicology
Enveda Biosciences
full-time
Posted on:
Location Type: Remote
Location: Remote • Colorado • 🇺🇸 United States
Visit company websiteSalary
💰 $215,000 - $230,000 per year
Job Level
Lead
About the role
- Leverage your experience in Toxicology to successfully bring drugs from the bench to the clinic.
- Be part of the Non-Clinical Drug Safety (NCS) Team, reporting to the VP/Head of Nonclinical Drug Safety.
- Work cross-functionally in the Drug Development Team to contribute to our mission of expediting drug development to the clinic.
- Use your knowledge of Preclinical/Nonclinical Development, and all the FDA Guidance to Industry and ICH Regulatory Guidelines in support of Clinical Development.
Requirements
- PhD, or similar advanced degree with DABT
- 10+ years executing non-clinical strategies and leading toxicology programs
- Demonstrated success in timely IND and Regulatory submissions, submission of the IND-enabling package (safety pharmacology and toxicology reports and SEND data)
- Good understanding of the FDA and ICH Regulatory Guidelines in Toxicology
- Demonstrated success in working with CROs for non-clinical studies in Safety Pharmacology (SP) and Toxicology in accordance with Good Laboratory Practices (GLP)
- Conduct of phase-appropriate IND-enabling and nonclinical toxicology studies
- Experience in Juvenile/Reprotox and Subchronic/Chronic studies, dermatology, inhalation or neuro programs, related toxicology studies, Carcinogenicity studies a plus
- Interpret and summarize toxicology findings and Author/review of Module 2 summaries: Module 2.6.2/2.6.3 Secondary and Safety Pharmacology, Module 2.6.6/2.6.7 Toxicology, Module 2.4 Nonclinical Overview (NCO), Investigator’s Brochure (Nonclinical sections)
- Ability to lead and manage simultaneous IND-enabling Programs with quality and integrity
- Ability to work independently and collaborate in a cross-functional Drug Development Team
Benefits
- 90% Medical, Dental,Vision
- 401k Match
- Flexible PTO
- Adoption Assistance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ToxicologyNonclinical DevelopmentIND submissionsRegulatory submissionsSafety pharmacologyGood Laboratory PracticesJuvenile studiesReprotox studiesChronic studiesCarcinogenicity studies
Soft skills
leadershipcollaborationindependenceproject managementcommunication
Certifications
PhDDABT
