This role will support the ALS Center's growth, ongoing clinical research work, and access to Expanded Access Programs. Early and Expanded Access Programs (EAPs) offer ethical and controlled access mechanisms to therapeutics outside of the clinical trial process to patients with life-threatening diseases. In collaboration with Associate Directors, the incumbent will support the adoption of genomic insights into clinical and public health guidelines, treatment pathways, and clinical management for ALS. In collaboration with research managers and clinical research coordinators, the incumbent will oversee clinical research activities and coordinate the recruitment of research families globally.
Plan, design, and execute EAPs according to the strategic objectives of the ALS center.
Responsible for the critical delivery and reporting of the overall success of EAPs
Write and coordinate the development of training manuals, treatment, and public health guidelines.
Develop Institutional Review Board (IRB) protocols and ensure compliance with IRB Standard Operating Procedures and applicable regulations in neuropsychological testing and neurological examinations.
Assist in study design and protocol development and collaborate with cross-functional teams in study start-up activities.
Provide programmatic oversight to ensure timely implementation of projects and contribute to reporting that conforms to ethical, safety, and quality standards and complies with Good Clinical Practice and regulatory standards.
Remain current on the therapeutic landscape in ALS by reviewing scientific literature, interacting with key opinion leaders, and attending relevant scientific meetings.
Actively participate in authoring of manuscripts, conference abstracts, and presentations.
Lead the development of best practices to build partnerships with public health and community organizations to ensure that the work of the Center is appropriately incorporated and positioned in public health guidance as well as treatment guidelines and protocols by providing balanced, scientific information.
Coordinate fundraising efforts and diversity and inclusion initiatives to improve access to EAPs.
Changes to individual responsibilities may occur due to the needs of the Center.
Advanced degree (i.e., Ph.D., M.D.) with relevant experience in clinical and collaborative research in neurodegenerative diseases.
Global experience, with a basic understanding of regional differences in clinical diagnostics, is required.
Experience with initiating collaborations and partnerships with academic researchers, hospitals, and professional societies.
Able to interpret scientific data, understand the impact of data on clinical approaches and research needs, and communicate scientific data to broad audiences.
Ability to independently deliver quality results promptly.
Ability to thrive in an ambiguous environment undergoing transformational change.
Excellent oral and presentation communication skills.
Master's in Public Health is preferred.
Master's in Bioethics is highly desirable.
Demonstrated successful experience writing grant applications.
Prior experience working with underserved communities and community organizations.
Columbia University is an Equal Opportunity Employer / Disability / Veteran
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.