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

A Scientific Director in the Rare, Orphan, and Pediatric Diseases (ROPD) Program will work with ROPD program leadership as well as an interdisciplinary team comprised of project managers, clinical, data and qualitative medicine scientists, and regulatory experts to advance novel drug development tools to address unmet medical needs for a variety of indications, such as alpha-1 antitrypsin deficiency, polycystic kidney disease, lysosomal diseases, bronchopulmonary dysplasia, and other rare, orphan or pediatric drug development topics.

Each Scientific Director (up to 3 positions) will be responsible for a group or groups of rare, orphan and pediatric diseases and help define strategies for data acquisition, work with the expert community to accelerate curation and interpretation of data and determine priority analysis and drug development and regulatory needs in those disease spaces. The Scientific Director will communicate broadly with the disease community (industry, academia, patient groups and government agencies) about the project and work with other scientific staff to support and develop regulatory-ready drug development tools.

The ideal candidate will work with program and project leadership to develop and execute the strategic plan and priorities and will be capable of leading both internal and external facing presentations and meetings with C-Path governance bodies, key opinion leaders and representatives from different stakeholder groups including clinicians, scientists, patient groups and regulators.

SUPERVISORY RESPONSIBILITIES

None

CORE DUTIES/RESPONSIBILITIES

•In collaboration with program leadership, provide scientific leadership and coordination as well as administrative oversight of activities.
•Provide scientific input to individual disease area discussions dealing with clinical and scientific issues relating to rare, orphan, and pediatric disease drug development, including data sharing and data use agreements, data standards, the sharing and analysis of data and the needs of disease communities to accelerate medical product development.
•Foster relationships with key individuals among regulatory bodies, companies, academics, patient groups, and other research initiatives or other collaborative efforts in the field.
•Establish and lead projects to support the development of drug development tools (models, biomarkers, clinical outcome assessments as appropriate), including developing research plans, task lists, milestones and timelines.
•Author or review internal and external communications, detailed research work plans, regulatory documents, and scientific publications.
•Provide input to strategic development planning and actively contribute to leadership activities at C-Path.
•Assist with annual budget development and manage expenditures.
•Travel on occasion for out-of-town meetings (approximately 10%).
•Other duties and responsibilities may be assigned.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

•Working knowledge of regulatory approval and the medical product development process, clinical trial design and statistics.
•Knowledge of FDA/EMA/PMDA regulations and requirements.
•Ability to drive collaboration and facilitate the scientific activities of diverse groups of stakeholders.
•Demonstrated ability to effectively present data, development plans and strategies to various audiences in both verbal and written form; demonstrated ability to author internal and external communication, scientific and regulatory documents that are clear and concise.
•Effective management, interpersonal, negotiation, strategic planning and problem-solving 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.
•Strong critical thinking and analytical skills.

REQUIRED EDUCATION AND EXPERIENCE

•A PhD or PharmD (or equivalent doctoral degree) in biological science, with experience in rare diseases.
•Four or more years' experience in medical product development (discovery, pharmacology, safety assessment, clinical development, or regulatory affairs) in academia, industry and/or government.
•Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of medical products, diagnostics, and/or devices.

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.

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