Senior Health Science Administrator

Duties
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• Director, DHA R/D Office of Human and Animal Research Oversight, including its Component Office of Human Research Protections, Cadaver Oversight, Office of Human Research Oversight, Animal Care and Use Review Office, Office of Regulated Activities.
• Manages a program of active compliance oversight of conducted and/or supported RDT and E, education, or training activities that use human cadavers and recommends approval of sensitive uses of cadavers to the Commanding General.
• Ensures OHRO's Office of Human Research Oversight's (OHRO) efficient and effective human research protection official administrative reviews, approvals, and oversight.
• Maintains familiarity with animal welfare regulations to ensure ACURO's Animal Care and Use Review Office's (ACURO) efficient and effective review, approval, and oversight of DoD-funded and conducted research use of animals.
• Directs the DHA's Human Research Protection Program (HRPP) Component Management Plan and coordination of Component-level human subjects protection regulatory compliance oversight of all DHA elements and subordinate institutions.
• Oversees all inspections and site assessment visits for DHA HRPPs and Institutional Review Boards, whether for-cause or for processes leading to approvals of Assurances. Oversees the establishment and maintenance of HRPPs in all DHA-wide activities.
• Provides leadership, planning, and direction to ensure an active and dynamic education, ethics, and compliance program for DHA human subjects protection systems, ensuring compliance with Federal- and DoD-specific regulations.
• Knowledgeable in U.S. Food and Drug Administration (FDA) regulations to effectively oversee ORA's management of its portfolio of FDA-regulated products and Sponsor's Representative activities supporting investigational new drugs and devices.
• Functions as the DHA Component Office of Human Research Protections (COHRP) Lead, the DHA's most senior-level authority and advisor in the field of DoD-conducted and DoD-supported human subjects research protections and regulatory compliance.
• Provides direct supervision of employees who lead the OHARO's subordinate offices: DHA COHRP, Cadaver Use Oversight, OHRO, ACURO, and ORA Office of Regulated Activities.
• Leads DHA COHRP initiatives for DHA-wide implementation of instructions, guidance, program development, ongoing quality improvement, and education regarding human research ethics, and human research protections required for DoD Assurances and HRPPs.
• Represents OHARO and DHA at high-level conferences and meetings. Participates in various DoD-level committees including the Executive Secretariat for the Coordinating Committee for Human Research Protection Programs.
• Directs integration activities with peers in other agencies.

Requirements
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Conditions of employment

• Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.
• This position requires the incumbent be able to obtain and maintain a determination of eligibility for a Secret security clearance or access for the duration of employment.
• This position has a Temporary Duty (TDY) or business travel requirement of up to 10% of the time.
• This position is supervisory as defined by the Office of Personnel Management's (OPM) General Schedule Supervisory Guide (GSSG). A one-year probation to assess your ability to perform supervisory duties is required unless previously completed.
• Appointment to this position is subject to a three-year probationary period unless the appointee has previously met the requirements as described in 5 CFR Part 315.
• This position requires you to submit a Public Financial Disclosure Report (OGE 278) or a Confidential Financial Disclosure Report (OGE450) upon entry, and annually thereafter.

Qualifications

Who May Apply: Only applicants who meet one of the employment authority categories below are eligible to apply for this job. You will be asked to identify which category or categories you meet, and to provide documents which prove you meet the category or categories you selected.

• Current Civilian Employees of the Defense Health Agency (DHA)
• Current Permanent Department of Defense (DoD) Civilian Employee
• Current Term Defense Health Agency HQs Research and Development Employee
• Priority Placement Program, DoD Military Reserve (MR) and National Guard (NG) Technician Eligible
• Priority Placement Program, DoD Military Spouse Preference (MSP) Eligible
• Priority Placement Program, DoD MR and NG Preference Eligible Tech Receiving Disability Retirement
• Priority Placement Program, DoD Retained Grade Preference Eligible

DHA Research & Development (R&D) is participating in an alternative personnel system known as the Personnel Demonstration Project (PDP). The DB-04 payband is equivalent to the GS-15 step 1 to GS-15 step 10 level. In keeping with the Demonstration pay fixing policies, employees earning a salary that falls within this payband equivalent may not receive an immediate pay increase (promotion) if appointed to this position. Future pay increases within the payband will be accomplished through the pay for performance management system.

In order to qualify, you must meet the education and experience requirements described below. 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; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document .

Basic Requirement for Senior Health Science Administrator:

Degree: Bachelor's or graduate (or higher level) degree with major study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of the position. This degree must be from an educational program accredited by an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.

You MUST submit copies of your transcripts supporting your education.

In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below:

Specialized Experience: One year of specialized experience which includes:

1. Experience applying and implementing human subjects research protections statutes, regulations, policies, and guidance to all types of human subjects research conducted in intramural and extramural research settings.
2. Experience conducting audits, site inspections, assessments, and/or investigations to ensure compliance with human research protection regulations and guidelines.
3. Experience providing oversight for research, development, testing, evaluation, education, and/or training activities that use human cadavers.
4. Experience interacting with varied groups and types of internal and external stakeholders to provide regulatory support across Food and Drug Administration (FDA) regulated research and product development efforts.

This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service (DB-03 / GS-14).

You will be evaluated on the basis of your level of competency in the following areas:

• Decision Making
• Leadership
• Oral Communication
• Problem Solving
• Research
• Writing

Education

Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show 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: https://sites.ed.gov/international/recognition-of-foreign-qualifications .

Additional information

• Male applicants born after December 31, 1959 must complete a Pre-Employment Certification Statement for Selective Service Registration.
• You will be required to provide proof of U.S. Citizenship.
• Extended Probationary Period: The length of the probationary period for the Engineers and Scientists Occupational Family will be three years.
  Direct Deposit of Pay is required.
• This position requires you to submit a Public Financial Disclosure Report (OGE 278) or a Confidential Financial Disclosure Report (OGE450) upon entry, and annually thereafter.
• Selection is subject to restrictions resulting from Department of Defense referral system for displaced employees.
• Recruitment or relocation incentives MAY be authorized for highly qualified candidates.
• Multiple positions may be filled from this announcement.
• Salary includes applicable locality pay or Local Market Supplement.
• If you have retired from federal service and you are interested in employment as a reemployed annuitant, see the information in the Reemployed Annuitant information sheet.
• Payment of Permanent Change of Station (PCS) costs is not authorized, based on a determination that a PCS move is not in the Government interest.