Director, Toxicology

Enveda • CO

96d • $215,000 - $230,000

About The Position

Join Enveda as a Director, Toxicology and help us transform natural compounds into life-changing medicines. We’re a team driven by curiosity and innovation, are you ready to make a difference? As a Director, Toxicology, you will leverage your experience in Toxicology to successfully bring drugs from the bench to the clinic. You will be part of the Non-Clinical Drug Safety (NCS) Team, reporting to the VP/Head of Nonclinical Drug Safety and working cross-functionally in the Drug Development Team, to contribute to our mission of expediting drug development to the clinic, and drug discovery. The role will require you to 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

Responsibilities

• IND-enabling activities including pre-clinical safety pharmacology (SP) and toxicology and further nonclinical development for drug approval
• Design and implementation of nonclinical development stage strategies for specific programs for small molecules
• Provide toxicology expertise to the discovery and portfolio programs
• Provide sound guidance to teams on dose selection and safety studies and risk assessments for discovery and developmental programs

Benefits

• 90% Medical, Dental, Vision
• 401k Match
• Flexible PTO
• Adoption Assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees