- 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 Chief Medical Officer 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.
Build Clinical Development Infrastructure
- You will work to ensure the effective and constructive integration of clinical operations knowledge and expertise into all Clinical Development activities including the creation of integrated development plans and study protocols.
- You will assist in the creation of clinical operations Standard Operating Procedures (SOPs), systems and processes across atai companies to ensure consistency and compliance with regulatory and other applicable standards and guidances.
- As the clinical team grows, you will supervise, develop, mentor, and assist in retention of clinical operations staff.
- You will assist in identification, qualification and establishment of preferred provider vendors to ensure consistent quality of outputs, and economies of scale and scope.
- You will assist in the development and implementation of Set and Setting protocols for trials with psychedelics in the treatment of psychiatric disorders.
- You will assist in building the Project Direction infrastructure to ensure coordination, prioritization of activities and proper resourcing in line with atai objectives.
- You will lead assist in the development of a Data Management function within atai.
Deliver on Clinical Development Objectives
- You will be the Clinical Development representative in Global Project Teams, and will have primary responsibility for delivering according to approved timelines and budgets.
- You will provide strategic and technical expertise to ensure that clinical development plans and individual trials are properly specified, planned and executed to meet scientific and regulatory goals.
- You will collaborate with key internal and portfolio company stakeholders including Commercial, Program Management, Regulatory Affairs, Legal, and Finance departments
- Collaborate with KOLs for feedback on study protocols and development plans.
- You will author key clinical documents (directly or through the involvement of clinical research organizations or consultants) such as: investigator brochures, clinical study protocols, informed consent forms, clinical study reports, briefing documents and management presentations.
- You will contribute to due diligence in the evaluation of business development opportunities
- You have a Doctoral degree (PhD or Pharm D degree) in Neuroscience or related disciplines. Knowledge of human electrophysiology or brain imaging biomarkers highly valued.
- You’ve worked 5 years or more in the pharmaceutical industry or in academic clinical trials, especially in leadership roles on a drug development project team.
- You have experience in early-stage Neuroscience drug development (Phases 1b, 2a, 2b).
- You have a proven track record of effective clinical support for regulatory submissions (e.g., IND, NDA, MAA, PIP)
- You have a strong track record in leading cross-functional teams in advancing projects
- You are highly empathetic with an outstanding ability to work multi-culturally
- You are willing to work in a challenging, fast-paced environment and to adapt to new situations as they arise
- You proactively seek out collaboration with other team members and are willing to develop, coach and motivate junior members of the team