This listing was posted on ApplicantList.
Scientific Director - Rare Disease Cures Accelerator
Location:
Tucson, AZ
Description:
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 Scientific Director for the Rare and Orphan Disease Program will work with leadership and an interdisciplinary team comprised of project managers, clinical, data and quantitative medicine scientists, and regulatory experts. The overall goal of this initiative is to advance novel drug development tools to address unmet medical needs for rare and ultra-rare neuromuscular diseases (NMDs). This position will be focused on muscular dystrophies and other NMDs, under joint supervision from the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) and Duchenne Regulatory Science Consortium (D-RSC) leadership. The ideal candidate will work with project leadership to develop and execute the strategic plan and priorities for the Rare and Orphan Disease program and will be capable of leading both internal and external facing presentations and meetings with Critical Path Institute (C-Path) governance bodies, key opinion leaders and representatives from different stakeholder groups including clinicians, research scientists, patient groups and regulators. SUPERVISORY RESPONSIBILITIES Project manager(s), administrative support staff, consultants and vendors. CORE DUTIES/RESPONSIBILITIES Collaborate with the RDCA-DAP and D-RSC leadership to provide overall scientific oversight of specified project activities. Establish and lead projects to support the development of drug development tools (quantitative models, biomarkers, clinical outcome assessments, as appropriate). Develop and guide the execution of research plans, task lists, objectives, and timelines for supporting RDCA-DAP and D-RSC deliverables and milestones. Provide scientific input to discussions dealing with clinical and scientific issues relating to the work of the program including the sharing and analysis of data. Lead teleconferences and attend key scientific conferences to ensure progress towards scientific, clinical, regulatory, and strategic objectives. Provide input to strategic development planning and actively contribute to leadership activities at C-Path. Author or review internal and external communications, regulatory documents, and scientific publications. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Ability to work collaboratively, think strategically, and use an inclusive and consultative approach to problem solving and decision making. Ability to effectively present data, development plans and strategies to various audiences in both verbal and written form; demonstrates ability to author internal and external communication, scientific and regulatory documents that are clear and concise. Knowledge of trial design, protocol development and regulatory requirements to test and evaluate hypothesis generated using real-world data and randomized clinical trial data. Understanding of appropriate FDA and EMA guidelines. An understanding of challenges to and opportunities currently presented in drug development for rare neuromuscular diseases based on drug development pipeline, pre-clinical and translational research. Ability to define data-driven milestones and deliverables and assess which outcome measure and clinically significant endpoints need to be pursued in future data negotiation for database implementation strategy. REQUIRED EDUCATION AND EXPERIENCE PhD ( or equivalent doctoral degree) with experience in rare diseases, previous work in rare neuromuscular disorders is strongly preferred. Previous experience in medical product development in academia, industry and/or government, is preferred. Experience in trial design, clinical endpoints development or digital health technologies is preferred. Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of medical products, diagnostics, and/or devices. Experience interacting with regulators is preferred. 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 ay be added, or this description amended at any time. Covid-19 In accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, C-Path has adopted a policy to comply with this requirement. All C-Path employees must vaccinate to safeguard the health of our employees and their families and the community at large from COVID-19. 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. Job Posted by ApplicantPro
Company:
Critical Path Institute
Posted:
January 25 on ApplicantList
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to ApplicantList
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Scientific Director - Rare Disease Cures Accelerator
Scientific Director - Rare Disease Cures Accelerator is a Executive Director Job at Critical Path Institute located in Tucson AZ. Find other listings like Scientific Director - Rare Disease Cures Accelerator by searching Oodle for Executive Director Jobs.
Scientific Director - Rare Disease Cures Accelerator is a Executive Director Job at Critical Path Institute located in Tucson AZ. Find other listings like Scientific Director - Rare Disease Cures Accelerator by searching Oodle for Executive Director Jobs.