JOB PURPOSE
atai LIFE SCIENCES is a patient-focused, innovation-driven company that will inspire you and empower you to grow professionally. We are seeking a dynamic and innovative medical director/ senior director who is accountable for developing innovative clinical strategies that will urgently improve standard of care and address our patients' unmet medical needs.
The Medical Director will be highly innovative and take bold steps to generate early clinical data by designing bold, better-powered, data-rich studies that significantly reduce the time it takes to bring medicines to patients, control costs & boost efficiency without compromise on quality and safety.
The Medical Director will ensure that atai LIFE SCIENCES conducts clinical development activities following these principles:
- Place the wellbeing of people who experience mental health disorders that we endeavor to heal at the center of our efforts in clinical development. Our choices of endpoints align with patients’ outcomes priorities.
- Appropriately mitigate risks to people who choose to participate in our trials, and to ensure that evaluations and procedures in our protocols don’t unduly burden them. Seek the most efficient use of patients’ contributions and development resources to generate high quality data that support global registration of new treatments.
- Pursue scientific truth with rigorous application of state-of-the-art designs, methods and technologies.
- Ensure that treatments in our pipeline are accessible to those who need them with use of digital technologies to lessen the burden on the delivery of novel mental health care
KEY RESPONSIBILITIES/ACCOUNTABILITIES
In this role, the Medical Director has a key role in the development of strategies for clinical programs and designs the trials in cooperation with key internal and external stakeholders. The Medical Director is a key contributor to the program teams, where they provide medical and technical leadership. The Medical Director implements, monitors, or evaluates clinical trials in relevant clinical development programs. The Medical Director will lead the study teams in interpreting trial results and in constructing the study reports. The Medical Director will take responsibility to ensure all reports and literature from the clinical program are scientifically sound and accurate and will identify issues that require further study and/or expert evaluation. As such, the Medical Director will work closely with internal cross-functional stakeholders, external investigators, various corporate partners and regulatory authorities.
DETAILED RESPONSIBILITIES/ACCOUNTABILITIES
- Provides medical expertise on clinical drug development throughout life-cycle of the compound:
- Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material.
- 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.
- Provides therapeutic training relevant to specific study to the project team.
- Attends and/or presents at investigator, internal and external project team meetings.
- Assesses and evaluates protocol deviations and recommends on actions to be taken.
- Assumes responsibility for ethical and medical, aspects of study.
- Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients.
- Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.
- Assists the clinical team in selection and recruitment of investigational sites.
- Develop clinical trial programs to support early decision-mking, product registration and marketing.
- Establish ongoing liaison with key opinion leaders, government officials, and healthcare organizations and ensure that significant developments in the field are identified and monitored.
- Provide leadership and medical expertise in the development of clinical development strategy.
- Provide medical and scientific input to global product development teams.
- Provide medical expertise in the review of adverse experiences locally and contribute to global pharmacovigilance activities.
- Supports generation of publications and expert reports:
- Reviews and interprets study results and clinical study reports.
- Generates expert reports and supports IAS/IAEs, NDAs/PLAs, and other regulatory submissions, as well as generates and/or reviews publications, posters, and scientific presentations.
- Presents clinical data and represents atai Life Sciences at professional meetings and meetings with authorities.
- Represents Clinical Development at internal meetings.
- Other duties as assigned.
- Travel may be required approximately 20% of time, primarily for medical meetings, site visits, and meetings with authorities.
KEY ATTRIBUTES/SKILLS/EDUCATION
Education, Certification and Technical Expertise
- Industry experience required with full understanding of safety, rules and regulations of industry.
- 5 years of drug development experience is recommended, preferably within the industry and with neurologic or psychiatric drugs. Experience with neurocognitive and/or Alzheimer’s programs is a plus.
- Board certification with a specialty in psychiatry preferred.
- Active Medical license preferred.
- Possess a working understanding of applicable US and EU regulations, the drug development process, biostatistics and pharmacokinetics.
Leadership
- Excellent oral and written communication skills and experience with publications.
- Ability to work collaboratively in a dynamic team-based environment.
- Embraces and demonstrates a diversity and inclusion mindset and models these behaviors for the organization
- Strong team player
- Excellent communicator, able to persuasively convey ideas verbally and in writing, and ability to distill complex issues and ideas down to simple comprehensible terms