Contract Duration: 12 months
Work Hours: 40 hours/week
Position Type: Fixed-term contract
Location: DE / UK
The Senior Manager, Clinical Operations is responsible for the strategic planning, oversight, and execution of clinical trials within atai Life Sciences. This role requires someone with a minimum of 5 years of industry experience who is adept at managing multiple projects, ensuring clinical trials are conducted in compliance with regulatory standards, and leading cross-functional teams.
This role sits within atai’s Development Chapter. The Development Chapter has overall ownership of trial design and conduct for the compounds that we are developing. They create and implement our global clinical development strategy, trial execution, and oversee our 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 in Berlin, New York City, and San Diego.
What you will achieve:
Within your first 30 days at atai, you'll immerse yourself in our clinical trials and processes, forging key relationships with teams and partners. By day 60, you'll be leading the day-to-day activities, actively shaping clinical strategies, in execution mode on the clinical trials, and ensuring cross-functional team needs are met. Approaching 90 days, you'll have complete ownership of a robust strategy for your clinical trials for the upcoming quarters, ensuring clinical operations are streamlined and compliant, while fully integrating into our company culture, driving projects forward, and championing a high-performing team ethos.
The specifics of your day-to-day will include:
- Lead the planning, execution, and management of complex clinical trials to ensure timely completion and adherence to budget.
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, Clinical Sciences, and Data Management, to align clinical operations with broader company objectives.
- Oversee the selection and management of Contract Research Organizations (CROs) and other third-party vendors.
- Ensure clinical trials are conducted in compliance with ICH Good Clinical Practice (GCP), FDA, EMA, and other relevant regulatory requirements.
- Act as a key contact for operational and tactical issues both internally and with external partners.
- Implement risk management strategies to identify, evaluate, and mitigate risks associated with clinical studies.
- Oversee the development and maintenance of clinical trial documentation, including study protocols, patient-informed consent forms, and study reports.
- Stay up to date with industry trends, best practices, and regulatory changes, ensuring the company remains compliant and competitive.
- Assist in the development and management of the department's budget.
Qualifications / experience that we'd like to see:
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related field. Advanced degrees are a plus.
- Minimum of 5 years of industry experience in clinical operations, with a proven track record of leading and executing clinical trials.
- Strong knowledge of ICH and global regulatory requirements.
- Exceptional leadership skills, with experience managing teams.
- Strong organizational and project management skills with the ability to manage multiple projects simultaneously.
- Excellent communication and interpersonal skills, with the ability to collaborate across departments.
- Proficiency with clinical trial management systems and electronic data capture.
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.