This position is located in the Department of Health and Human Services, Administration for Strategic Preparedness and Response, headquartered in Washington, District of Columbia. This announcement serves as a public notice to appoint individuals under the Senior Biomedical Research and Biomedical Product Assessment Service Authority.

Duties

WHAT YOU'LL BE DOING DAY TO DAY The Director of the Division of Research, Innovation & Ventures (DRIVe), within the Office of BARDA, under the Office of the Assistant Secretary for Preparedness & Response (ASPR) will perform the following duties: In consultation with the BARDA Director and the Director of MCM Programs, defines, organizes, directs and manages DRIVe and all assigned resources to ensure a collaborative and comprehensive HHS strategy. Arranges for the execution of and supervises DRIVe projects which are assigned to ASPR Divisions, HHS Departments, other U.S. Government activities, individuals, private business entities, educational institutions, or research institutions, giving consideration to the primary functions of ASPR Divisions and HHS Departments. Functions as an interface between BARDA, entrepreneurs, start-up firms, not-for-profits and commercial technology companies to increase HHS, ASPR, BARDA and DRIVe access to leading-edge technologies and technical talent. Identifies technology investment priorities while considering preparedness and response needs and national health priorities, including anticipating potential future needs. Considers the industrial or commercial base necessary to meet the needs and directly engages through public private partnerships in research and development opportunities to foster new medical countermeasure innovation for life saving national security needs. Supports development and submission of DRIVe's budget needs and status to MCM Program Director to support various financial related requests. Recommends courses of action to the MCM Program Director or as requested, takes courses of action to resolve major problems and concerns including those that may be sensitive in nature and require particularly delicate negotiation or other forms of resolution.

Requirements

• U.S. Citizenship required
• Males born after December 31, 1959 must be registered or exempt from Selective Service - http://www.sss.gov
• Suitable for federal employment
• Meet time in grade restrictions by the closing date of the announcement
• Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. All information concerning qualifications is subject to investigation.
• Documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.
• All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choice.
• All qualification requirements must be met by the closing date.
• Financial disclosure statement will be required.
• Probationary (or trial) period may be required.
• Incumbent must submit to and successfully pass a urinalysis drug screening prior to appointment. The incumbent will also be subject to unannounced random drug testing for the duration of their time in this position.
• The Incumbent of this position will have the ability to obtain and maintain a Top-Secret Clearance.

Qualifications

WHAT WE ARE LOOKING FOR Eligibility and Qualification Requirements: To be eligible for an SBRBPAS appointment, the individual must have a doctoral level degree in biomedicine or a related biological field, or a doctoral or master's level degree in engineering, bioinformatics, or a related or emerging field and meet the OPM Qualification Standards for a General Schedule (GS) 15 level position in the 0601 Occupational Series which can be found here General Health Science Series 0601 (opm.gov) (42 U.S.C. §237(b) and 42 CFR §24.4). In addition, the individual must be considered an expert in at least one (1) of the following fields (42 CFR §24.4): Biomedical research. An individual actively engaged in original biomedical research, including behavioral research, and whose work in this area is considered by recognized experts or peers in the field of biomedical research to be outstanding. One or more of the following achievements must be present to demonstrate the individual has received such recognition: the individual a) conducted original biomedical research published in peer-reviewed journals of high stature; b) received major prizes and awards (such as visiting professorships and named lectureships) in recognition of original contributions to biomedical research; c) received invitations to speak at or chair major national or international meetings or symposia; d) elected to membership in professional societies of high stature, or e) meets other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related field that is necessary to accomplish the OpDiv/StaffDiv's mission. Clinical research evaluation. An individual who is actively engaged in clinical research evaluation and whose work in this area is considered by recognized experts or peers in the field of clinical research evaluation to be outstanding. One or more of the following achievements must be present to demonstrate the individual has received such recognition: the individual a) has significant experience dealing with complex, precedent-setting evaluation issues, including those arising during product development that involved significant scientific controversy, had far-reaching implications for clinical research or resulted in a widespread economic effect in the health-care delivery system; b) has taken an active role in the development of significant scientific or regulatory guidelines for clinical research evaluation, c) received invitations to speak at or to chair major national or international meetings and symposia; or d) meets other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related field that is necessary to the achievement of the OpDiv/StaffDiv's mission. Biomedical product assessment. An individual who is actively engaged in the development or assessment of biomedical products and whose work in this area is considered by recognized experts or peers in the field of biomedical product assessment to be outstanding. One or more of the following achievements must be present to demonstrate the individual has received such recognition: the individual a) has significant experience dealing with complex, precedent-setting evaluation, scientific policies, or development issues (e.g., those associated with novel biomedical products, novel approaches to the biomedical product- manufacturing, or use of novel evaluation methods); b) demonstrated cutting-edge expertise in a scientific or technical discipline critical to design, development, manufacturing, clinical performance assessment, or technical aspects of effective oversight of biomedical products; c) played a leadership role in planning and conducting public meetings to seek public input and communicate scientific, regulatory policies; d) received invitations to speak at or chair major national or international meets and symposia; or e) meets other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related activity or field that is necessary to the achievement of the OpDiv/StaffDiv's mission. Mandatory Qualifications : A PhD and/or MD degree and work experience demonstrating a high degree of relevant technical, scientific and leadership competency. Biotech/Pharma Industry Experience, highly valuable. At least three (3) years of experience leading large, diverse, dynamic organizations, with diverse experience, skills, and backgrounds. At least five (5) years' experience in strategic planning and developing and implementing innovative initiatives and budgeting. Professional knowledge and experience in the translational research, development, manufacture, clinical evaluation and/or regulation of products and technologies pertinent to the DRIVe portfolio. Strong oral and written communication skills, particularly with respect to communicating complex policy and programmatic issues to diverse audiences including senior management, subordinates, managerial and professional peers, and external stakeholders on routine basis and emergency response situations. Commitment to effective EEO policy and programs. Desirable Qualifications Knowledge of Federal programs, regulations, statutes, policies, and directives which govern programs in the public health emergency preparedness arena relevant to the areas of DRIVe focus. Experience in the research and development of pharmaceutical products or devices or medical countermeasures. Experience demonstrating the successful management of an organization requiring (1) skill in the formulation, presentation, and execution of a budget; (2) conducting cost effectiveness studies and developing long-range planning models; (3) development of comprehensive action plans for the resolution of complex organizational and operational problems; (4) leading or supporting medical product launches. Experience with leading dynamic, technically diverse organizations and projects. Experience growing and maturing R&D-focused organizations, in govt, philanthropy, or the private sector. Experience leading technically sophisticated innovation programs that require challenging and strengthening an organization's current strategy and assumptions prior to consensus. Experience implementing programs focused on quality assessment and improvement. Demonstrated ability to operate effectively in a highly dynamic and evolving environment. Documenting experience: IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. Do not copy and paste the duties, specialized experience, or occupational application questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.

Education

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov.

Note: Applications can be accepted from students who expect to complete qualifying education within 9 months from the date of application. Education was completed successfully before the applicant can be appointed.

Contacts

• Address Administration for Strategic Preparedness and Response 200 Independence Ave. SW Washington, DC 20201 US
• Name: SROC Help Desk
• Email: [email protected]