TASKS/SERVICES. The contractor shall:
(1) Provide expert leadership, advice and authoritative guidance to the Division of Translational Research (DTR) within the National Institute of Neurological Disorders and Stroke (NINDS) to assist in preparing and managing cooperative agreements.
(2) Manage a portfolio of drug discovery projects with trans-NIH scope including responsibility aspects of administration (i.e., organizing and managing); apply drug discovery expertise, secures and implements scientific advice from Program Directors and the Division Director
(3) Define project objectives; plans, executes, and finalizes projects according to strict deadlines and within budget; oversees quality control, assembles data and reports on program budgets.
(4) Prepare and review data packages to support and defend recommendations to DTR, NINDS and NIH in forums such as NIH HEAL related meetings, NINDS Extramural Science Committee and NINDS Council meetings
(5) Make presentations to senior level Institute and NIH Administrators, advocacy groups and non-governmental groups interested in the Division of Translational Research scientific process.
(6) Build, develop, and grow worldwide collaborative relationships among government, academia, and industry that are focused on the search for therapeutic interventions and treatments for neurological disorders. Work with prospective investigators to identify compounds with potential as pain and neurological disease therapeutics
(7) Provide directly or arrange for the necessary chemistry, pharmacology, neuroscience, and experimental design expertise to advance the translational and therapy development efforts as part of the NINDS mission
(8) Develop and implement quantitative and qualitative reviews of milestones to determine if they appropriately translate into accelerated progress of therapeutic candidates toward Investigational New Drug (IND) applications to the FDA and provide clear indicators of a project's continued success or emergent difficulties.
(9) Perform project site visits and work with investigators from various institutions, laboratories, and industry who seek assistance in drug development, all conducted in accordance with NIH policies (including use of animals) and NINDS goals and objectives.
(10) Expertly reviews and abstracts scientific material from technical sources including research grant progress reports and scientific journals and oversees the preparation of responses. Advises the scientific community of research needs, opportunities, and advancements using funding opportunity announcements (FOAs) and Requests for Proposals (RFPs). Utilizes the latest professional guidance and technical competence and takes a lead role in staff discussions and providing recommendations on program policy and development.
(11) Reviews, analyzes, evaluates and recommend preclinical therapeutic research plans aimed at IND submission to determine if project plans are achievable, have defined interim goals, have realistic but aggressive schedules, and include reliable indictors of a project’s successful progress.
(12) Substantively participates in meetings entailing discussion of submissions (e.g., IND and pre-IND applications) with expert reviewers at the FDA.
(13) Review and update portfolio management activities consistent with updates to NIH/DHHS policies and procedures, and works closely with affected staff in the coordination of early notification, implementation, etc.
REQUIREMENTS. The contractor ideally would have:
(1) Ph.D. in health science, medical or allied scientific field, such as biology, microbiology, pharmacology, public health or chemistry
(2) More than 10 years of experience in the pharmaceutical industry or equivalent setting that includes leading cross-discipline teams engaged in the preclinical drug discovery process from lead identification through clinical candidate selection
(3) Demonstrated project leadership experience with comprehensive, milestone-driven drug discovery or development programs, from the hit identification stage to early phase clinical studies. Mastery of quantitative and qualitative methods to assess the progress of preclinical and early phase clinical development of new therapeutic interventions for neurological disorders.
(4) Thorough understanding of drug discovery and development and sensitivity to political, scientific, medical community and media issues sufficient to promote cooperative agreements and to review project milestones and advise on continued funding
(5) Expert knowledge of the regulations, policies, practices and procedures of the FDA regarding nonclinical and clinical development of new chemical entities.
(6) Expert skill performing complex analysis and evaluations to develop solutions to new or problematic situations, initiate actions for resolution, and develop short-and long-range plans to accomplish program objectives.
(7) Ability to make clear presentations and provide expert-level guidance, participate in meetings and workshops, speak at conferences, relay issues and progress to higher levels of authority, and interact with respected scientists and researchers in various organizations.
(8) Excellent communication and interpersonal skills with ability to build relationships to gain the trust and confidence of internal and external stakeholders, strong networking skills, demonstrated experience in effective communications working across all levels of the organization
(9) Excellent organizational, time management and analytical skills to meet deadlines, prioritize and coordinate several projects simultaneously, and to manage a dynamic and growing portfolio of interdisciplinary drug development projects.
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