Section Chief

Trial Innovation Network Section Chief, Division of Clinical Innovation, Clinical Affairs Branch

National Institutes of Health
National Center for Advancing Translational Sciences
Division of Clinical Innovation

Clinical Affairs Branch
Bethesda, Maryland

 

Description

NCATS, a major research component of NIH, seeks applications from exceptional candidates for a Trial Innovation Network section chief position in the center’s Division of Clinical Innovation (DCI). Candidates should have recognized leadership and demonstrated expertise in improving clinical trial efficiency through tool development, clinical trial training and education. The selected candidate also will be expected to broaden the scope of clinical trial questions and the clinical trial enterprise so that trials address the health concerns of people in a broad variety of situations and locations, including those living in rural and remote locations, individuals of diverse cultures and beliefs, and minority populations.

The section chief will be responsible for developing a strategy to test, disseminate and incorporate the tools developed by this section and from other parts of the NCATS Trial Innovation Network, ensuring the dissemination and sustainability of these tools within NCATS-funded programs, NIH and the extramural research community. Dissemination should include a variety of organization types and geographic locations. To facilitate this, the Trial Innovation Network section chief will work with clinical trial networks and training programs through NIH and non-NIH programs to ensure that the tools are accessible and used appropriately. This process will be iterative and bilateral, such that suggestions and requests from collaborators will be provided back to the Trial Innovation Network to make sure the needs of participants, families, communities, providers and researchers are optimized. To this end, community engagement will be important to enhance the tool development process, increase uptake and dissemination, and ensure that the necessary types of tools are developed.

Clinical trials are balanced by understanding efficacy/effectiveness and outcome measures, but safety is paramount. Therefore, the section chief will be responsible for tool development that highlights, flags or streamlines safety issues and will lead clinical safety protocol activities within DCI. The position will be within the Clinical Affairs Branch of DCI, which supports the NCATS Trial Innovation Network and The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®. 

Core Responsibilities

The Trial Innovation Network section chief will be responsible for providing authoritative, technical and scientific leadership and guidance for the clinical trial activities within DCI and when needed by NCATS and NIH. The section chief will direct the activities of the section, including providing a national resource for rapid response to public health emergencies via the Trial Innovation Network and promoting the identification, development and dissemination of innovative clinical trial designs and recruitment strategies. The section chief will develop and provide resources for the planning, implementation and conduct of NIH-supported clinical trials. The section’s products and resources aim to improve clinical trial efficiency, maximize safety and enhance the types of information within clinical trials. Examples of the activities within the section will include the implementation of techniques/tools to enhance trial design, site selection efficiency, Institutional Review Board efficiency, startup and expansion efficiency, realistic cost, and time calculations for both NIH and investigator expectations, personnel, and site turnover issues.

The section chief will serve as a senior leader, representing DCI and NCATS in clinical, research and clinical trial training/career development programs across NIH, other government agencies, industry, academia and patient-support organizations. The section chief will provide advice to the clinical affairs branch chief and the DCI director on trial-, safety- and clinical-related matters. The section chief will also work to diversify the clinical trial landscape by working in coordination with the various components of DCI, including the Education and Training Section of the Clinical and Translational Science Awards (CTSA) Program Branch. The CTSA Program Branch supports the CTSA Program, an innovative national network of more than 60 medical research centers that aims to improve human health by transforming the research and training environment to enhance the efficiency and quality of clinical and translational research. 

Qualifications

The successful candidate will have a Medical Doctorate (M.D.), an active state medical license, and real-world experience in academia or industry in clinical trial development and conduct. The successful candidate will have experience in trial bottlenecks/barriers, optimization strategies and potential efficiencies. An important aspect of the position will be safety; therefore, the successful candidate will have extensive experience with clinical safety issues. The successful candidate also will have strong and demonstratable experience in conceiving, developing and testing tools to support clinical trials in novel groups and settings. The successful candidate will also have a strong history of working with diverse federal and nonfederal organizations and partners.

The successful candidate must have extensive experience in (1) leading a diverse, highly complex research program and employing strategies for implementing and disseminating research tools and products; (2) providing expert advice to senior leaders on scientific and clinically relevant policies and programs; (3) developing innovative training programs for advancing clinical tool development, dissemination and usage by trainees; and (4) leading teams. The successful candidate must appreciate new trends in the clinical trial enterprise, such as the novel use of informatics, big data and site-selection strategies to improve the conduct of trials. The successful candidate will have the ability to communicate and collaborate well with others.

Candidates should demonstrate (1) a clear pattern of success in setting, planning, implementing and analyzing research projects, program objectives and priorities; (2) the ability to communicate and collaborate effectively with diverse scientific and lay audiences; and (3) the ability to form collaborations with national and international organizations, as well as with individuals who represent wide-ranging disciplines and competing priorities.

Salary/Benefits

Salary is commensurate with qualifications, experience and accomplishments; a full civil service package of benefits — including retirement; health, life and long-term care insurance; and Thrift Savings Plan (401[k] equivalent) participation — is available.