Homeoffice Director, Toxicology bei Envedabio

Let’s build the future of medicine - together.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?Remote | Full Time | $215,000 - $230,000 What Makes Us Enveda Life is smart, and we can learn  from it. We’re reinventing drug discovery by harnessing nature’s intelligence. Our platform identifies new medicines four times faster than the industry standard because patients can’t wait. What sets Enveda apart isn’t just what we do,it’s how we do it. Our culture is built on creativity, collaboration, and deep respect for each other. We believe “People Create All Value”, and our success is driven by the extraordinary team turning our mission into reality every day.We’re proud of the momentum we’ve built:Jan 2024: Named a LinkedIn “Top Startup to Watch” Mar 2024: Forbes America’s Best Startup Employers Oct 2024: First drug to Phase 1 Clinical TrialsAug 2025: Raised 150M Series D, gaining Unicorn statusThese milestones reflect the impact of our team and we’re just getting started, but they’re only possible because of the diverse talent, perspectives, and relentless drive of our team, and people like you.Your Role in Our MissionAs 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.

What You’ll Do

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

We’re Looking For:

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

Jetzt bewerben