ABOUT CRITICAL PATH INSTITUTE (C-PATH)

Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For over ten years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world.

POSITION OVERVIEW

The Executive Director is responsible for the overall strategic planning, management, and activities of collaborative research endeavors with various stakeholders to accomplish objectives of the Critical Path for Alzheimer's Disease (CPAD) Consortium. The Executive Director of CPAD will coordinate initiative projects, provide operational excellence, financial oversight, and project implementation management for the CPAD Consortium. The CPAD ED communicates the vision of the consortium to key stakeholders, including pharma, academic, and government participants; existing and potential funders; strategic partners and the scientific community through talks and scientific publications.

SUPERVISORY RESPONSIBILITIES

Manages consortium staff including scientific directors, project managers, and project coordinators to support CPAD deliverables.

CORE DUTIES/RESPONSIBILITIES

• Provide overall leadership, and administrative and scientific oversight of CPAD's activities.
• Lead scientific evaluation of clinical and scientific issues relating to the work of the consortium including data sharing, model informed drug-development (MIDD), biomarker, and clinical outcome assessments (COA) as appropriate.
• Foster relationships with key individuals among regulatory bodies, consortium members, other research initiatives or other collaborative efforts in the field.
• Guide the execution of a detailed work plan and its milestones to develop, evaluate, and prepare applications for submission to the FDA/EMA the review and potential endorsement of MIDD tools, biomarkers, COAs, etc. for a specific use in drug development, as appropriate.
• Lead in business development opportunities by recruiting new organizations from pharmaceutical, biotechnology, and device industries for consortium membership.
• Collaborate/connect with research-performing organizations and other public-private partnerships working in the Alzheimer's disease drug development environment.
• Collaborate with other C-Path consortia and programs for innovative solutions that may be applied to CPAD's specific projects.
• Work with C-Path administration management to provide financial oversight of any grants or funds utilized to execute the work of the Initiative.
• Direct project manager(s) for the working groups to provide project. implementation/management/oversight/tracking of all collaborative efforts.
• Communicate the consortium's progress via scientific publications and presentations.
• Provide input to strategic development planning and actively contribute to leadership activities at C-Path.
• Manage vendors and consultant relationships.

REQUIRED KNOWLEDGE SKILLS AND ABILITIES

• General knowledge of neurodegeneration, drug development and regulatory processes; and the ability to maintain knowledge of recent advances in drug development for neurodegenerative diseases.
• Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of medical products, diagnostics, and/or devices.
• Working knowledge of assay development and validation, good laboratory and clinical practice, data science and biostatistical analysis.
• Working knowledge of regulatory approval and the drug development process.
• Knowledge of FDA/EMA/ICH regulations and requirements.
• Clear communication skills with a broad range of audiences (scientists, regulators, industry, patients) through clear presentation skills and writing skills.
• Highest level of integrity and core value system consistent with C-Path's code of conduct.
• Sound judgment when working with critical or confidential information.
• Ability to meet target deadlines, adapt to changing circumstances and manage time effectively.
• Working knowledge of scientific and clinical aspects of A