Critical Path Institute (C - Path)

The Associate Scientific Director (ASD) of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) will work with leadership and an interdisciplinary and cross functional teams comprised of project managers, clinical, data, and quantitative medicine scientists, and regulatory experts in coordinating collaborative endeavors with various stakeholders to accelerate the advancement of drug development tools.. The ASD will represent HD-RSC, CPTA, and the overarching CP-RND effort to diverse stakeholders (FDA, patient centered non-profits and pharma) and serve as a facilitator both internally and externally to help C-Path leadership and the CP-RND Executive Director evolve the strategy and implementation of the CPTA and HD-RSC research plans with the goal of translating scientific advances into drug development solutions as efficiently as possible.. Help coordinate strategy and functional operationality of consortia working groups related to generating and optimizing drug development tools (i.e., data analysis/quantitative modeling, biomarker development and qualification, clinical outcome assessment (COA) development and qualification, digital health technologies, etc. Liaise with C-Path's Rare Disease Cures Accelerator - Data and Analytics Platform (RDCDAP) program and other internal data and analytics teams (Data Collaboration Center and Quantitative Medicine Programs) and external data contributors.. A PhD (or equivalent doctoral degree) in a related scientific or medical discipline and two to four years' experience in drug development (drug discovery, mechanistic pharmacology, clinical development, project management or regulatory affairs in the pharmaceutical industry, at nonprofit research foundations, and/or the FDA).

associate director

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 Associate Scientific Director (ASD) of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) will work with leadership and an interdisciplinary and cross functional teams comprised of project managers, clinical, data, and quantitative medicine scientists, and regulatory experts in coordinating collaborative endeavors with various stakeholders to accelerate the advancement of drug development tools. This position will have an intended focus in Huntington's disease (HD) and rare inherited ataxias, through the Huntington's Disease Regulatory Science Consortium (HD-RSC), and the Critical Path to Therapeutics for the Ataxias (CPTA) Consortium. The ASD will be part of the HD-RSC and CPTA team working to define regulatory tools and expedite the approval of novel therapies to treat HD and spinocerebellar ataxias (SCAs). The ASD will represent HD-RSC, CPTA, and the overarching CP-RND effort to diverse stakeholders (FDA, patient centered non-profits and pharma) and serve as a facilitator both internally and externally to help C-Path leadership and the CP-RND Executive Director evolve the strategy and implementation of the CPTA and HD-RSC research plans with the goal of translating scientific advances into drug development solutions as efficiently as possible. Supervisory Responsibilities None at this time. Core Duties/Responsibilities Help coordinate strategy and functional operationality of consortia working groups related to generating and optimizing drug development tools (i.e., data analysis/quantitative modeling, biomarker development and qualification, clinical outcome assessment (COA) development and qualification, digital health technologies, etc.). <ul><li>Support the ED for CP-RND in development and execution of detailed work plans and associated milestones to generate, evaluate, and prepare applications for submission to the FDA/EMA for qualification of drug development tools.</li><li>Develop and foster positive relationships with all of the consortia's global stakeholders, including biotech/biopharmaceutical organizations, nonprofit research foundations, patient advocacy groups, regulators, and academic/clinician researchers. </li><li>Lead the consortia's data acquisition and database aggregation strategy, including curating a pipeline of high-value datasets to intake and integrate into the consortia's databases. </li><li>Liaise with C-Path's Rare Disease Cures Accelerator - Data and Analytics Platform (RDCA-DAP) program and other internal data and analytics teams (Data Collaboration Center and Quantitative Medicine Programs) and external data contributors.</li><li>Support ED for CP-RND and consortia workgroup co-leads in developing and executing consortia goals and enable progress towards scientific and strategic milestones and timelines while leveraging appropriate course correction, troubleshooting, or risk-mitigation strategies, as applicable.</li><li>Participate in disseminating scientific achievements/advances in peer-reviewed journals and other scientific venues.</li><li>Represent the HD-RSC and CPTA consortia at national and international scientific or regulatory meetings. </li><li>Serve as point of contact for individual consortium members (i.e., workgroup co-chairs, participants, new members) to provide scientific information and coordination with other members of the consortium.</li><li>Support developing strong, positive, professional relationships with regulatory authorities, government agencies, research organizations, patient advocacy groups, etc., (within established policies and compliance standards) and continually look to form relationships and strategic partnerships that will further C-Path's mission. </li></ul>Required Knowledge, Skills And Abilities <ul><li>Strong critical thinking and analytical skills</li><li>Expertise in managing productivity of complex collaborations and research teams.</li><li>Track best practices and lessons learned and operationalize to develop recommendations for the future.</li><li>Nimbly adapt to shifting priorities and timelines</li><li>Identify opportunities for improvement and make constructive suggestions for change</li><li>Practice highest level of integrity and core value system consistent with C-Path's code of conduct</li><li>Ability to meet target deadlines and manage time effectively</li><li>Demonstrated negotiation skills and ability to cultivate and grow external relationships</li><li>Prior experience in evaluating milestones and the context/information provided by external vendors/partners.</li><li>Ability to successfully anticipate issues or challenges and proactively address them without being specifically directed</li><li>Demonstrated experience in medical/scientific writing and earnestness to support the writing and submission from inception to completion, of regulatory submissions and publications in peer reviewed scientific journals. </li></ul>Essential Prerequisites <ul><li>Strong publication record</li><li>Scientific track record of success </li></ul>Preferred Skills/experience <ul><li>Experience in drug development in rare neurodegenerative diseases is preferred.</li><li>Knowledge of good laboratory and clinical practices</li><li>Knowledge of FDA/EMA regulations for clinical development</li><li>Knowledge of data science, working with databases, clinical expertise </li></ul>Required Education And Experience <ul><li>A PhD (or equivalent doctoral degree) in a related scientific or medical discipline and two to four years' experience in drug development (drug discovery, mechanistic pharmacology, clinical development, project management or regulatory affairs in the pharmaceutical industry, at nonprofit research foundations, and/or the FDA). </li><li>Training and professional experience in drug development in neurological disorders. </li></ul>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. 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

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