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 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 is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained change in mental health patients.
atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life.
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 SVP 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 and TPP to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
- Assume 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, pre-IND meetings and IND submissions.
- Maintain scientific and clinical knowledge in relevant therapeutic and disease areas and provides scientific input across chapters, as needed, when appropriate.
- Champion Good Clinical Practice standards in all clinical development activities.
Qualifications / experience that we'd like to see:
- Industry experience required with full understanding of safety and rules and regulations of industry.
- 5 years of drug development experience within the industry is recommended, preferably and with neurology or psychiatry indications.
- Board certification with a specialty in psychiatry preferred.
- Active Medical license preferred.
- Demonstrated expertise in the concepts 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.
- A track record that showcases successful interactions with regulatory affairs authorities, international societies, and other key stakeholders..
- Leadership skills are a must, with several years of experience in a matrix environment and a proventrack record of guiding teams towards shared goals.
- Decision-making skills should be effective and efficient, prioritizing clarity and simplicity, able to focus on what matters most to drive meaningful results.
Who will be successful in this role
:
- Demonstrated ability to thrive in the face of uncertainty and scarcity while embracing new challenges.
- Strong team playerwith a hands-on approach. Adaptable and keen to tackle issues together. Our resilient teamwork leads to effective solutions and shared success
- Excellent communicator, able to persuasively convey ideas verbally and in writing, and ability to distill complex issues and ideas down to simple comprehensible terms
- Embraces and demonstrates a diversity and inclusion mindset and models these behaviors for the organization
Those who succeed at atai also align with our values of Rooted in Purpose, Seeing Opportunity Where Others See None, Work the Problem and Keep It Simple
