Clinical Project Manager III - Sickle Cell Disease (NHLBI)

The Clinical Monitoring Research Program Directorate (CMRPD) is assisting National Heart, Lung, and Blood Institute (NHLBI) to develop and implement a well-defined Program Management and Support Services (PMSS) framework and infrastructure that can quickly integrate project/program management and other support functions under a matrixed team concept, committing personnel and expertise from multiple organizations within the Institute. This PMSS will directly support major NHLBI initiatives and will allow for implementing robust project management processes and procedures across the Institute through training efforts, policy development, change management strategies, and other means as may be necessary. The NHLBI provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide. NHLBI anticipates that the PMSS will manage multiple Large-Scale Complex Initiatives that will involve program management coordination and support of personnel from organizations across the NHLBI, multi-tiered governance structures, national level stakeholders, and multiple awardees that are performing work as a consortium under Other Transaction Agreements. Although precise needs of each initiative will vary, the Key Role/Responsibilities of the NHLBI Cure Sickle Cell Initiative provides a sense of the scope of work involved with these kinds of initiatives.

KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL

• Facilitate communications and engagement of researchers and other related stakeholders in the early translational sciences of heart, lung, and blood research including novel therapies for sickle cell disease and cross-cutting early translational research, among others.
• Management of a consortium of awardees related to pre-clinical studies, translational, clinical, implementation and data science; economic research; and enabling tools and technology.
• Develop public-private partnerships and collaboration among government agencies, private sector entities, researchers, and others to result in more rapid advancement of new and innovative treatments and technologies.
• This position is located at NIH/NHLBI, Office of the Executive Offices, Building 31, Suite 5A48 (or similar location), 31 Center Drive, Bethesda, Maryland, 20892

BASIC QUALIFICATIONS

• Master's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for U.S. equivalency
• A minimum of ten (10) years of progressively responsible, relevant experience in early translational, pre-clinical, and/or clinical research, including a minimum of six (6) years directly managing multiple concurrent clinical projects
• Experience leading scientific research projects or clinical trials by overseeing and integrating all aspects of the effort, setting deadlines, assigning responsibilities, monitoring and summarizing progress of project and program
• Previous project management and/or study coordination experience including data management, and research subcontracting
• Extensive knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
• Experience related to clinical operations (e.g., development of Standard Operating Procedures (SOPs), staff development and training, resourcing/staffing, and budget planning and execution)
• Ability to excel in fluid working environments and adapt to changing priorities.
• Ability to adapt and perform under innovative business, project and funding mechanisms.
• Must be detail-oriented, creative and flexible
• Strong organizational skills and the ability to prioritize multiple tasks and projects
• Exceptional written and oral communication skills
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• PhD degree
• Superior program management skills, as well as senior level scientific and/or technical gravitas
• Ability to lead early translational research initiatives associated with novel or emerging therapies
• Familiarity and experience with federal government programs
• Ability to independently manage and prioritize multiple complex projects
• Ability to work in a busy setting, both independently and within a team
• Ability to effectively communicate and collaborate across divisions and programs and with numerous external stakeholders
• Ability to attend meetings as a program liaison
• Ability to create and maintain business processes and write, interpret and implement various policies and procedures, ensuring smooth operations within the program
• Willingness to perform tasks that may fall outside of the normal daily responsibilities
• Proficiency with Microsoft software applications

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)