Job Title: Principal Investigator (PI) - Clinical Trials Location: Ottawa/Montreal Position Type: Full-time, Permanent Job Summary: We are seeking a highly skilled and experienced Principal Investigator (PI) to lead and oversee clinical trials within our organization. The PI will be responsible for ensuring the successful execution, oversight, and compliance of clinical studies in accordance with regulatory guidelines, ethical standards, and the scientific objectives of the research. This role requires a deep understanding of clinical trial methodologies, patient safety, data integrity, and regulatory requirements, as well as the ability to lead a multidisciplinary team and interact with stakeholders at all levels. Key Responsibilities: Leadership and Oversight: - Lead and manage Sponsors' implementation, and execution of clinical trials from protocol development to study completion. - Ensure all clinical trial activities are conducted in compliance with Good Clinical Practice (GCP), institutional guidelines, and regulatory requirements. - Provide medical and scientific leadership and expertise throughout the trial process, ensuring scientific rigor and adherence to the research objectives. Protocol Development and Study Design: - Collaborate with stakeholders (research teams, sponsors, regulatory bodies) to develop study protocols, case report forms (CRFs), and other essential study documents. - Study and educate staff on protocol's inclusion/exclusion criteria, endpoints, and other key components of the clinical trial design. Patient Safety and Welfare: - Oversee the safety and well-being of study participants, ensuring appropriate monitoring and timely reporting of adverse events (AEs) and serious adverse events (SAEs). - Ensure informed consent is obtained from all participants, and that participants' rights and confidentiality are protected throughout the study. Regulatory Compliance and Documentation: - Ensure all necessary regulatory submissions are completed and approved in a timely manner (e.g., IRB/ethics committee approvals, IND/NDA submissions). - Oversee accurate and complete data collection, source documentation, and timely reporting of study results in compliance with regulatory agencies (Health Canada, FDA, EMA, etc.). Collaboration and Communication: - Serve as the primary point of contact for external stakeholders, including sponsors, regulatory agencies, and monitoring teams. - Communicate regularly with the clinical trial team, including research coordinators, data managers, research assistants and other key personnel, to ensure smooth trial operations. Training and Mentorship: - Provide ongoing education and guidance to clinical research staff, including clinical research associates (CRAs), coordinators, and other personnel. - Mentor junior investigators and other staff, fostering a culture of professional development, ethical standards, and high-quality research. Data Integrity and Reporting: - Ensure that clinical data is accurately recorded, and monitored in accordance with study protocols. - Contribute to the preparation of clinical trial reports, manuscripts, and publications based on study findings. Continuous Improvement: - Monitor and evaluate trial progress, ensuring any issues or obstacles are addressed in a timely manner. - Identify opportunities for process improvements and contribute to the development of best practices within the clinical trial research environment. Qualifications: Education & Experience: - MD, PhD, NP, PharmD, or equivalent in a relevant scientific or medical discipline. - Board certification in a relevant field (preferred). - A minimum of 5-10 years of experience in clinical research, including experience as a PI in clinical trials. - Experience with clinical trial design, GCP, and regulatory guidelines. Skills & Competencies: - Strong knowledge of clinical trial design, GCP, FDA, ICH, and other applicable regulatory guidelines. - Exceptional leadership, project management, and organizational skills. - Ability to lead and manage multidisciplinary teams, prioritize tasks, and resolve conflicts. - Excellent communication skills, both written and verbal, with the ability to effectively present data and findings. - Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC) systems (experience with CRIO is an asset, not a requirement), and other research-related tools. Other Requirements: - Ability to work collaboratively and thrive in a fast-paced, dynamic research environment. - Strong problem-solving and decision-making skills. - Willingness to travel, if necessary, for site visits, monitoring, and meetings. Preferred Qualifications: - Experience in CNS specific therapeutic areas will be preferred. Compensation and Benefits: - Competitive salary, commensurate with experience. - Comprehensive benefits package, including health, dental, vision, and RRSP match program. - Opportunities for career development, continuing education, and professional growth.