Director of Pharmaceutical Research Management

5 days ago

Rockville, Maryland, United States National Institutes of Health Full time
Job Summary

The National Institutes of Health (NIH) is seeking a visionary and experienced leader to serve as the Director of Pharmaceutical Research Management in the Office of Pharmaceutical Research Management (OPRM). As a key member of the Division of Allergy, Immunology, and Transplantation (DAIT), the successful candidate will play a critical role in shaping the future of pharmaceutical research and development.

The Director of Pharmaceutical Research Management will provide strategic direction, guidance, and oversight of pharmacy and pharmaceutical activities to all DAIT staff and DAIT-supported investigators. This includes:

  • Providing scientific knowledge, leadership, and direction on all pharmaceutical aspects of clinical protocol development and conduct
  • Ensuring study participant safety and assessing the clinical trial stability and feasibility of all DAIT-supported national and international clinical trials
  • Developing a manufacturing and distribution strategy for pharmaceutical products for Phase 1 through 4 clinical trials
  • Providing investigational product management and pharmacy and pharmaceutical support and oversight for DAIT-funded clinical trials
  • Serving as the authority on the use of pharmaceuticals in DAIT-funded clinical trials
  • Ensuring compliance with applicable national and international regulations governing the management of investigational products
Required Qualifications

To be eligible for this position, candidates must be a U.S. citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. Candidates must possess either a doctoral-level degree in biomedicine or a biological related field, or a masters level or higher degree in:

  • Engineering
  • Bioinformatics
  • Or an emerging or related scientific field

Candidates must also have at least one year of experience related to the position, including achievements in one or more of the following areas:

  • 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 healthcare delivery system
  • Active role in the development of significant scientific or regulatory guidelines for clinical research evaluation
  • Invitations to speak at or chair major national or international meetings and symposia
  • Other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related field necessary to the accomplishment of NIH's mission

If you are a current Federal Title 5 employee, you must have one year of equivalent experience at the GS-14 level or above.

Benefits

A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.

Equal Employment Opportunity

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

Standards of Conduct/Financial Disclosure

If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency.

Foreign Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer.

Reasonable Accommodation

You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.

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