Join a fast-paced, collaborative, results-driven, and meritocratic environment, reporting to the VP of Clinical Operations, and work with world-class scientists and clinicians to build Clinical Operations Digital Therapeutics Infrastructure and deliver on Clinical Operations DTx Objectives.
atai’s Development Chapter designs and conducts clinical trials for the compounds that we are developing. They create and implement our global clinical development strategy, trial execution, and networking with external partners.
Who we are:
atai Life Sciences is a biopharmaceutical company focused on developing novel treatments for mental health disorders so that everyone, everywhere, can live a more fulfilled life. To achieve this, we are developing psychedelic and non-psychedelic compounds and cutting-edge digital therapeutic tools, and we are excited about anything that might mean a true leap forward for our patients. We operate a hybrid virtual/in-person working model, with most of the team spending 2-3 days in the office, and our hubs are located in Berlin, London, New York City, Boston, and San Diego.
What we offer:
- Compensation package inclusive of yearly bonus and generous stock options
- Annual company offsite in the U.S or Europe
- Hub visits to our offices in Berlin, Boston, London, New York City, and San Diego
- Hybrid work model with 2-3 days in office, and home office budget
- Mental health wellness program, including 10 company-paid therapy sessions a year
- Sports Club membership (Class Pass, Urban Sports Club)
- 100% paid medical insurance for the UK and 50% employer contribution for DE
- 100% employer-matched pension scheme for DE & UK
What you will achieve:
- You will work to ensure the effective integration of atai’s digital therapeutics (DTx) and digital biomarkers to the clinical trial pipeline using your clinical operations, DTx, and data management skills and knowledge
- You will provide your DTx clinical knowledge to all Clinical Development activities including the creation of integrated development plans and studies, and drive the planning, approvals, and execution of protocols that include DTx.
- 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 the retention of clinical operations staff, building a data management branch within the operations team.
- 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 building the infrastructure to ensure coordination, prioritization of activities, and proper resourcing in line with atai objectives.
The specifics of your day-to-day will include:
- You will be the Clinical Operations DTx 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
Qualifications / experience that we'd like to see:
- You have a bachelor's degree in Neuroscience or related disciplines. Advanced degrees are highly valued also.
- Knowledge of DTx deployment in clinical trials is indispensable. Knowledge about digital biomarkers and their clinical development is highly valued.
- You’ve worked 7 years or more in the pharmaceutical industry, especially in leadership roles on a drug or device development project team.
- You have a background in digital therapeutics, medical devices, or device/drug combinations with a solid understanding of ICH/GCP, data capture, database designs, ePRO, eCOA, eConsent, and a strong interest in evolutions in the data management field
- You have experience in early-stage drug development (Phases 1b, 2a, 2b), with experience in combination drug/device development. Additionally, experience in Neuroscience development is highly valued.
- 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
Who will be successful in this role:
Those who succeed at atai will be strongly aligned with our values:
- ❤️ Conscious Care: We take every action in service of our ultimate goal: to heal mental health disorders for all while caring for ourselves and our team.
- 🦸 Bold Entrepreneurship: We are “loosely coupled but tightly aligned” as we strive for excellence over perfection, fast and focused to accelerate innovation for patients.
- 🧑🤝🧑 Collaborative Innovation: individuals and teams work together with good humor and no drama, valuing different perspectives and diversity of thought, background, nationality, and style.
- ✋ Radical Responsibility: We take full responsibility for our circumstances. We grow and learn from failures, always looking to improve.