Location: Remote, preferably either on the west or east coast
- Atai Life Sciences provides a fast-paced, collaborative, results-driven and meritocratic environment where you will work with world-class scientists and clinicians in the development of psychedelics and other innovative experimental drugs in several psychiatric indications.
- Atai is a vibrant, multi-cultural start-up that values fast learning and scientific curiosity and supports professional growth.
- Being based remotely this position gives you the opportunity to work from where you want to be, and with the device and equipment you choose.
- You will report directly to the VP of Early Development, so your contributions will have an immediate impact.
- You will also have the opportunity to participate in the company's success via a share option plan.
- Strategically plan, manage, oversee, and/or execute nonclinical activities required for candidate selection, IND enablement, and clinical support including, non-human pharmacology studies, toxicology studies, bioanalytical assay development and sample analysis.
- Oversee CROs and other external resources and ensure quality results are delivered on time and within budget. This includes study design, protocol development, coordination of study materials, data interpretation, report review and approval.
- Use internal and external (CRO) resources to design, develop, troubleshoot, transfer, and monitor qualification/validation/reporting of DMPK programs to support nonclinical development activities.
- Develop and integrate timelines and budgets for nonclinical activities with overall company timelines and corporate goals, in close coordination with Program Management, CMC, Clinical, Regulatory groups and other stakeholders.
- Successfully interact with other functional area experts in a project team environment to recommend the best course of preclinical development for a given program and defend those recommendations to executive management.
- Work together with atai regulatory personnel to prepare relevant sections of regulatory submission documents as well as preclinical sections of Investigators Brochures, CTA applications, IMPDs, etc.
- Works with atai’s lead of early development to prioritize programs, meet program timelines and objectives, and communicate program progress to senior management.
- PhD in Toxicology or related field or DVM with a minimum of 10 years of relevant industry experience.
- DABT certification is highly desired.
- Track record of toxicology and DMPK leadership on multiple programs at early and late stages of development.
- Direct experience developing the toxicology strategy and data package supporting the clinical development of small molecule therapeutics.
- Firm understanding of pharmacokinetics and modeling human dosing.
- Proven track record of conducting drug safety assessment studies, and ability to make sound risk assessments and representing toxicology perspectives on project teams and external stakeholders.
- Experience with EMA and FDA CTA/IND and BLA submissions and regulatory interactions.
- Experience partnering with Regulatory Affairs, Clinical, CMC and Early Development colleagues to ensure comprehensive nonclinical approaches are developed as part of the program strategy.
- Extensive experience working with strategic outsourcing and study coordination.
- Ability to pivot and perform in fast-paced, dynamic, evolving environment.
- Excellent communication and organizational skills and attention to detail.
- Strong time management skills; ability to prioritize multiple tasks efficiently.
How to apply
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