FDA- Deputy Super Office Director for Operations

1 month ago

silver spring, United States AE Strategies Full time

The Deputy Super Office Director for Operations at the Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)


Position Overview: The Deputy Super Office Director for Operations at the Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), shares responsibility with the Super Office Director to formulate and set operational strategies. The incumbent provides executive-level leadership, overseeing regulatory operations, strategic planning, program effectiveness, and quality management. This role is pivotal in ensuring the efficient execution of the office’s programmatic and regulatory functions, maintaining the highest standards of public health and safety.


Employee Value Proposition (EVP): This position offers a unique opportunity to impact public health on a national scale by leading operations across the FDA’s Center for Drug Evaluation and Research. The role is ideal for an experienced executive leader passionate about drug evaluation and regulatory science, seeking to drive innovation and operational excellence in a mission-critical organization. The incumbent will work with a diverse team of experts dedicated to ensuring the safety and effectiveness of drugs available to the American public.


Company Culture Overview: The FDA operates in a fast-paced, highly regulated environment where precision and adherence to strict standards are paramount. The successful candidate will thrive in a collaborative setting that values scientific integrity, innovation, and public service. The leadership style within the Office promotes transparency, accountability, and a commitment to continuous improvement.


EEO responsibilities: The incumbent is responsible for furthering the goals of equal employment opportunity (EEO) by taking positive steps to assure the accomplishment of affirmative action objectives and by adhering to non-discriminatory employee practices in regard to 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.


Strategic Planning and Implementation:

  • Lead the formulation and execution of the Office's strategic directions in collaboration with the Office Director and other leaders.
  • Oversee the development and monitoring of short- and long-range organizational goals, ensuring alignment with CDER and FDA priorities.
  • Communicate strategic plans and performance metrics across the organization, ensuring all stakeholders are engaged and informed.

Operational Leadership and Performance Evaluation:

  • Ensure CDER’s objectives and goals maintain alignment with regulatory obligations.
  • Regularly evaluate program effectiveness, analyzing workload and performance data to identify and address gaps.
  • Provide executive-level reports on program performance, ensuring transparency and accountability.

Regulatory and Scientific Program Oversight:

  • Provide expert leadership in regulatory and scientific review processes, ensuring consistency and efficiency across all sub-units.
  • Represent the Office at internal and external meetings, offering scientific and regulatory guidance.
  • Lead initiatives to enhance review management practices and facilitate interactions with industry stakeholders.

Quality Management:

  • Direct and oversee the Office’s quality management program, ensuring adherence to FDA’s quality standards.
  • Implement and monitor quality control systems to detect and correct non-conformances quickly.
  • Promote a culture of continuous improvement, leading efforts to enhance processes and performance metrics.

Stakeholder Collaboration and Change Management:

  • Foster collaboration with other FDA offices and external stakeholders to ensure cohesive regulatory operations.
  • Lead change management initiatives, ensuring that all organizational changes are implemented smoothly and effectively.
  • Develop and implement strategic initiatives requiring cross-functional collaboration to meet regulatory objectives.


General Medical and Healthcare Series, 0601: Degree: Bachelor’s or graduate/higher level degree: 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 from an accrediting body recognized by the U.S. Department of Education at the at the time the degree was obtained.


Desired Skills, Experience, or Education:


  • Executive leadership experience with an established record of accomplishment in leading organizations of significant size and complexity.
  • Effective communicator who can drive collaboration, empower staff, and is committed to the Public Health mission.
  • Demonstrate the ability and experience coordinating complex work and priorities and building coalitions with partners in other organizations.
  • Ability to drive collaboration, empower staff, provide expert advice and consultation, coordinate program activities, and spearhead important program initiatives.
  • Knowledge of leadership principles and concepts regulating and evaluating new drugs and biological products.
  • Ability to manage and lead a diverse interdisciplinary staff.

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