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 Alzheimer's disease, including general understanding of immunology and the ability to maintain knowledge of recent advances in neurodegeneration drug development.
• Strong critical thinking and analytical skills.
• Effective management, interpersonal, negotiation, strategic planning and problem-solving skills.
• Ability to adapt to shifting priorities, demands, and timelines.

REQUIRED EDUCATION AND EXPERIENCE

• An MD, PharmD, or equivalent clinical degree, or a PhD in a relevant scientific discipline is preferred or any equivalent combination of education and experience in neurodegeneration.
• Seven to ten years' experience in drug development (drug discovery, mechanistic pharmacology, safety assessment, clinical development, project management or regulatory affairs in the pharmaceutical industry and/or FDA/EMA).
• Three to five years' experience managing individual and team members.
• Proven experience with the design, conduct, and reporting of experiments or studies relevant to applications of novel efficacy or safety biomarkers, or preclinical efficacy models.
• Proven experience leading and managing complex teams and deliverables.
• Proven experience facilitating scientific activities of diverse groups of stakeholders toward improving the conduct of regulated drug studies.

Critical Path Institute is an equal opportunity employer. Visit our website at www.c-path.org

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Reasonable Accommodation:

Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible. Accommodations will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department.