Evidence Generation Program Lead - 2406159744W

　　Description

　　Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Evidence Generation Program Lead located in Toronto, Canada.

　　At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at https://www.janssen.com/canada/ and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

　　The Evidence Generation Program Lead is responsible for the management of all aspects of evidence generation (EG) activities for assigned programs (defined as a portfolio of evidence generation and publication projects that support a specific therapy area, disease, or indication). They will partner with the Medical Science Directors, Scientific Advisors, Market Access Strategic Team Leads and Managers to achieve successful delivery of evidence generation and real-world evidence (RWE) activities at the program level. The Evidence Generation Program Lead will follow clinical research project management principles to meet company and regulatory requirements according to time, quality, scope, and budget constraints. They will collaborate with internal and external partners, lead the contractual arrangements, protocols and study documents development, governance, and compliance approvals within their programs, as well as lead the end-to-end operations including vendor management, procurement, budget and resources.

　　This critical role will bring its technical, scientific, and operational expertise in the development and the implementation of the Integrated Evidence Generation Plan(s) within the assigned therapy area(s). This dynamic role will proactively lead SMT, including a network of Subject Matter Experts (SMEs), to support the setup and execution of RWE projects from conceptualization until publication. Through collaborations with relevant partners, execution excellence of evidence generation projects according to quality, budgetary and timeline specifications is a core responsibility for this role.

　　Primary responsibilities:

　　Program leadership:

　　Proactively lead program level operational aspects of studies including management of study timeline, budget, resources, and vendors.

　　Contributes to the development of the publication plan, including post-hoc analysis of the available datasets.

　　Acts as the main point of contact for the global development- medical affairs operation department in charge of execution prospective local studies.

　　Operational Leadership

　　Ensure effective project plans are in place and operational for each study and proactively lead the Study Management Team (SMT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

　　Manage the program budget, make updates, and ensure reporting based on cycles defined by finance.

　　Lead study startup process, including but not limited to project internal approvals, protocol and study document development, review and approval, vendor (or data custodian) selection, qualification, and contracting.

　　Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and find opportunities to improve training, execution, and quality control across the study team.

　　Review and approve vendor invoices in collaboration with the accounting team to ensure investigator and vendor payments occur in a timely manner.

　　Communication and Collaboration

　　Chair SMT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members, and filed in the TMF in a timely manner.

　　Leads and coordinates interactions with collaborators to ensure that studies align with regulatory obligations, follow quality standards and that the results are published according to the plan and the defined deadlines.

　　Provide efficient updates on trial progress to the Manager, Evidence Generation Operations with respect to vendor selection, project plans, trial budget and timeline management, and risk mitigation.

　　Other duties including implementation and establishment of the EG/RWE operational foundations may be assigned.

　　Qualifications

　　Bachelor’s degree in Life Sciences, Epidemiology, Nursing Licensure, Pharmacy, or related scientific field is required. Master’s degree or higher is preferred.

　　3 years clinical operations and/or RWE experience; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.

　　5 years of clinical/RWE project management experience at a sponsor or CRO company is preferred

　　Experience in the design, methodologies, classification, and execution of observational research studies is preferred

　　Therapeutic experience in oncology, immunology and/or rare diseases is preferred

　　Thorough knowledge of clinical research concepts, practices, and regulatory regulations or ICH Guidelines regarding drug development phases, clinical research, and data management methods is required

　　Read, write, and speak fluent English, excellent verbal, and written communication skills.

　　Highly organized and able to manage multiple tasks and prioritize work to deliver on timelines and key deliverables.

　　Ability to work individually (independently) as well as on a team.

　　Meticulous, with strong attention to detail, accuracy, and process adherence.

　　Highly developed interpersonal, influencing and communication skills to build and maintain effective partnerships with all collaborators.

　　Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

　　For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

　　Primary Location NA-CA-Ontario-Toronto

　　Organization Janssen Inc. (7710)

　　Job Function Medical Affairs

　　Req ID: 2406159744W