Hiring Can Be Simple!

The Senior Director of Toxicology will be responsible for building the overall toxicology strategy and targeted toxicology packages to support regulatory submissions for small molecule drug discovery programs from IND to NDA. The successful candidate will have substantial experience in CNS drug development and the ability to contribute effectively to cross-functional drug development teams. They will manage CROs to conduct regulatory-compliant toxicology studies and lead the outsourcing efforts for the design, monitoring, execution, and reporting of all nonclinical toxicology studies. As the nonclinical Safety Assessment lead for multiple programs, they will evaluate and author responses to inquiries from health authorities.

Qualifications & Experience

• Ph.D. in Toxicology, Pharmacology, Biology, or related discipline with 10+ years of pharmaceutical industry experience in neuroscience drug development toxicology

• Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations

• Deep understanding of QA, regulatory, and clinical functions for nonclinical safety assessment activities

• Experience serving as the Safety Assessment lead in cross-functional drug development teams

• Experience in authoring non-clinical elements of major regulatory submissions and responding to regulatory inquiries

• Successful outsourcing and monitoring of toxicology studies with CROs

• Previous interaction with FDA Psychiatry and Neurology divisions is highly desirable

• Detail-oriented, able to function well in a hands-on environment

• Excellent verbal communication and scientific writing skills for study reports and regulatory documents

An exciting opportunity for a Senior Director of Nonclinical Safety (Toxicology) to join a growing organization. This role will lead the nonclinical safety strategy and execution for programs across discovery, nonclinical, and clinical stages. It will also oversee aspects of investigative toxicology, strategic review and interpretation of all non-GLP and GLP toxicology studies, the nonclinical safety budget, and collaborate with team members, project teams, and external partners to ensure alignment and drive excellence in nonclinical safety practices.

The position will report to the Senior Vice President of Nonclinical Sciences.

Qualifications:

• PhD/DVM in Toxicology or related field with 15+ years of experience in the pharmaceutical/biotech industry

• Experience in nonclinical GLP toxicology and safety assessment of Small Molecule Drugs

• Knowledge of GLP regulatory requirements and FDA responses

• Strong leadership and management skills

• Excellent communication and organizational skills

• Attention to detail, quality, and compliance

• Ability to lead in a dynamic, fast-paced environment

Our client is forefront of pioneering discoveries in the field of neurology. They are dedicated to making a difference in the lives of patients by harnessing the power of data and innovation. Now, they are looking for a Director of Biostatistics to join their talented team and make a lasting impact.

As a Director of Biostatistics, you will be at the helm of their clinical research endeavors, driving progress and making a significant contribution to the world of neurology.

Your responsibilities will include:
Interpreting and analyzing complex data with finesse.
Juggling multiple projects effortlessly, without dropping the ball.
Communicating exceptionally well, especially with complex data and visualizations.
Collaborating seamlessly with diverse teams.
Influencing biotech's approach to managing clinical trial data.
Representing Biostatistics on core project teams for operational and strategic decisions.

What You Bring:
We're seeking a dynamic and hands-on Biostatistician who can bring their expertise to the front lines of our client's groundbreaking clinical research.
You should be a Statistical Maestro: You make data sing and dance to your tune.
A Project Juggler: Handling multiple projects simultaneously is second nature to you.
A Communication Virtuoso: You excel at simplifying complex data and visualizations.
A Collaborative Guru: Working seamlessly with diverse teams is your superpower.