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.

  • 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...

  • FDA- Deputy Super Office Director for Operations

    2 months 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...

  • FDA- Deputy Super Office Director for Operations

    2 months 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...

  • FDA- Deputy Super Office Director for Operations

    2 weeks ago

    Silver Spring, MD, 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...

  • Deputy Super Office Director for Operations

    4 weeks ago

    Silver Spring, Maryland, 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), plays a pivotal role in shaping the office's operational strategies. This executive-level position oversees regulatory operations, strategic planning, program effectiveness, and quality...

  • Deputy Director for Operations

    4 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    Job Title: Deputy Super Office Director for OperationsAt AE Strategies, we are seeking a highly experienced and skilled Deputy Super Office Director for Operations to join our team. This is a unique opportunity to impact public health on a national scale by leading operations across the FDA's Center for Drug Evaluation and Research.Job Summary:The Deputy...

  • Deputy Super Office Director for Operations at the Office of New Drugs, Center for Drug Evaluation and Research

    3 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    {"Job Overview:As the Deputy Super Office Director for Operations at the Office of New Drugs, Center for Drug Evaluation and Research, you will share responsibility with the Super Office Director to formulate and set operational strategies. This role is pivotal in ensuring the efficient execution of the office's programmatic and regulatory functions,...

  • FDA - Physician - Trial Reviewer - Urologist

    2 months ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Clinical Reviewer - Dermatologist

    8 months ago

    Silver Spring, United States AE Strategies Full time

    Medical officers at FDA perform duties that:ensuring all human drugs manufactured for interstate sale are safe and effective with truthful and informative product labelingensuring the safety, potency, purity and effectiveness of vaccines, blood products, certain diagnostic products and other biological and biotechnology-derived human productsensuring the...

  • FDA - Physician - Trial Reviewer - Urologist Oncology

    5 months ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Trial Reviewer - Hematology Oncology

    1 month ago

    silver spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Trial Reviewer - Hematology Oncology

    3 weeks ago

    silver spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Trial Reviewer - Hematology Oncology

    2 weeks ago

    Silver Spring, MD, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • Director of Operations

    3 weeks ago

    Silver Spring, United States Integrity National Full time

    Location: Nationwide (up to 75% travel required) Reports To: Chief Operating Officer Job Type: Full-Time, Exempt Salary Range: $150k-$165k based on experience and credentials (Eligible for a 15% bonus) Application Deadline: Open until filled About the Role: We are seeking a highly experienced leader with a robust background in operations within the...

  • Senior Grants Manager

    4 weeks ago

    Silver Spring, Maryland, United States Panagora Group Full time

    Job Title: Senior Grants ManagerJob Summary:Panagora Group is a leading provider of innovative solutions in global health and international development. We are seeking a highly skilled Senior Grants Manager to support the implementation of a large global grants under contract program.Key Responsibilities:Support the Director of Grants with the successful...

  • Executive Director Of Branch Operations

    3 weeks ago

    Silver Spring, United States YMCA Full time

    Make a difference while advancing your career at the YMCA of Metropolitan Washington! Job Description We are a leading non-profit organization dedicated to strengthening communities through youth development, healthy living, and social responsibility. We are currently seeking a highly motivated and experienced individual to join our team as an Executive...

  • Executive Director of Branch Operations

    3 weeks ago

    Silver Spring, Maryland, United States YMCA Full time

    Advance your career with a leading non-profit organization dedicated to strengthening communities through youth development, healthy living, and social responsibility. As an Executive Director of Branch Operations, you will oversee all operations of a Y branch, including membership, healthy living, aquatics, early learning, school age enrichment, summer...

  • Medical Director of Nursing Services

    4 weeks ago

    Silver Spring, Maryland, United States National Children's Center Full time

    Director of Nursing Job DescriptionNational Children's Center is seeking a highly qualified Director of Nursing to join our team. As a key member of our Community Support Services team, you will be responsible for managing and coordinating nursing services to support the health and well-being of our clients.Key Responsibilities:Ensure the delivery of...

  • Bilingual Assistant Program Director

    4 weeks ago

    Silver Spring, Maryland, United States National Youth Advocate Program Full time

    Job SummaryThe Assistant Program Director will assist the Program Director in ensuring the delivery of long-term foster care services to unaccompanied minors. This role will provide support with programmatic, administrative, financial, and operational systems, and serve as a liaison with the Office of Refugee Resettlement.ResponsibilitiesPerform duties in a...

  • Chief Operating Officer

    2 weeks ago

    Silver Spring, United States The Redda Group Corporation Full time

    Redda Group has been retained by a high-growth general contracting and real estate development firm based in the DC/MD area, currently generates $20 million in revenue and holds an equity base of $50 million. The Company is pursuing an ambitious growth trajectory to reach $500 million in annual revenue and $1 billion in equity by 2030. The COO will play a...