The Medical Director/Senior Director is responsible for working cross-functionally to oversee/co-lead the design and development of Phase 1-3 clinical trials. The Clinical Development Director must be highly innovative and take bold steps to generate early clinical data by designing well-powered, data-rich studies that significantly reduce the time it takes to bring medicines to patients, control costs & boost efficiency without compromising on quality and safety.
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 1-2 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 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 UK, and 50% employer contribution for DE
- 100% employer matched pension scheme for DE & UK
What you will achieve:
Within your first month, you will accelerate your learning about atai and the programs that you are leading: develop a good understanding of the company culture and background scientific knowledge specific to the programs that you are responsible for.
During your first 3 months, you will secure early wins by contributing meaningfully to programs, building personal credibility and aligning on strategy, skills and culture.
By the end of your first 6 months, a successful candidate will have led the development of assigned clinical development plans (CDP) and clinical trials; and served as a clinical representative on cross-functional teams responsible for the implementation, monitoring, analysis, and reporting of these studies.
The specifics of your day-to-day will include:
- Drive/contribute to the conceptualization and design of assigned clinical development plans (CDP) and clinical trials with guidance and oversight from the Vice President of Clinical Development, as well as act as a clinical representative on cross-functional teams responsible for the implementation, monitoring, analysis, and reporting of these studies. This requires close and frequent interactions with other functions including operations, biometrics, safety, regulatory affairs and a variety of business and commercial functions.
- Ensure that all protocol documents are high quality and align with the CDP to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
- Assumes responsibility for ethical and medical, aspects of study. Provides or supervises medical monitoring including answering site questions on inclusion/exclusion criteria or other protocol questions, evaluating SAEs and AEs, reviewing laboratory and other safety parameters, patient profiles, medical history coded terms, concomitant medications, and provides medical expertise to project teams during life-cycle of study.
- Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirements, including scientific advice, IND, EoP2, pre-NDA meetings, NDA and MAA documents.
- Maintain scientific and clinical knowledge in relevant therapeutic and disease areas and provides scientific input across chapters, as needed, when appropriate.
- Responsible for ensuring the Go/No-Go criteria have been set for the study.
- Engage and influence a diverse scientific community of internal and external experts and collaborators, including the formation and management of expert advisory groups.
Qualifications / experience that we'd like to see:
- Industry experience required with full understanding of safety, rules and regulations of industry.
- 5 years of drug development experience within the industry is recommended, preferably with neurology or psychiatry indications.
- Board certification with a specialty in psychiatry preferred.
- Active Medical license preferred.
- Demonstrated expertise in the fundamentals of clinical trial methodology, study design, endpoint selection, protocol writing, clinical trial implementation and conduct, data quality, data analysis, results interpretation, and report authoring.
- Ability to evaluate, interpret & synthesize scientific data, and to verbally present and critically discuss clinical trial and published data in internal and external meetings.
- Possess a working understanding of applicable US and EU regulations, the drug development process, biostatistics and pharmacokinetics.
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.