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Director, Division of Research, Innovation & Ventures (DRIVe) | Director in Executive Job at U1

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Director, Division of Research, Innovation & Ventures (DRIVe)

Location:
Washington, DC
Description:

Summary 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 Conditions of Employment 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 theirtime 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 (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. How You Will Be Evaluated You will be evaluated for this job based on how well you meet the qualifications above. Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS. In accordance with Executive Order 12564 of September 14, 1986, The Department of Health and Human Services (HHS) is A Drug-Free Federal Workplace. The use of illegal drugs, on or off duty, by Federal employees is inconsistent not only with the law-abiding behavior expected of all citizens, but also with the special trust placed in such employees as servants of the public.Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the application questionnaire to determine if you are qualified for this job. If, after reviewing your resume and or supporting documentation, a determination is made that you have inflated your qualifications and or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility. This is a Public Notice: All candidates will be referred to the hiring agency.In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the "percentage of times" the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.Experience refers to paid and unpaid experience, including volunteer work done through national Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited.To preview the application questionnaire, click the following link: Required Documents Cover Letter: A cover letter is required to be submitted with your application package.Resume: You must submit a resume that provides: Personal information - your full name, email and mailing addresses, phone number Education information - the name of the school and the dates you attended Work experience - paid and unpaid work with the following information Job title Detailed duties and accomplishments Employer's name and address Supervisor's name and phone number Starting and ending dates (include the day, month, and year that you began and ended for each position held. Full-time employment will be assumed unless otherwise stated on your resume. Part-time employment will be prorated in crediting experience. Hours per week Salary, if applicable Other qualifications - skills, certifications/licenses, honors, awards, special accomplishments, and job-related training courses. For resume writing guidance, please visit the or view their . For Most Effective Resumes Tips visit: Veterans' Preference documentation Discharged Veterans: If you are claiming 5 point preference, you must submit a copy of your DD Form 214, Certificate of Release or Discharge from the armed forces that supports dates of service and discharge status; if claiming 10 point preference, an application for 10-Point Veterans Preference (SF-15) and an official document dated 1991 or later, from the Department of Veterans Affairs or from a branch of the Armed Forces, and/or any other associated documentation based on your preference. Proof of Disability: An official written document from the Department of Veterans Affairs or the Military Service Branch certifying your compensable service-connected disability rating. Your overall percentage must be clearly shown.Documentation supporting eligibility for non-competitive appointment, (severely disabled, eligible veterans, certain military spouses, etc.) A disability letter from you doctor or a licensed medical professional that proves your eligibility for Schedule A appointment. College Transcripts (if applicable): Please see the Education section of this announcement for detailed information about transcripts. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.You are not required to submit official documents at this time; copies are sufficient. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. PDN-9c19de51-bcb8-44b0-a255-db3cf32cc833
Company:
U.S. Department Of Health And Human Services
Industry:
Other
Posted:
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