Director, Scientific & Human Subjects Programs

Description

Leidos is seeking a high-performing Director to provide executive leadership, strategic oversight, and operational management for two mission‑critical scope areas within the Department of Energy (DOE): 1.) Scientific and Technical Resource Integration (STRI) and 2.) Human Subject Health and Protection Surveillance. This position is responsible for ensuring regulatory compliance, scientific integrity, technical excellence, stakeholder engagement, data governance, and program performance across complex, multidisciplinary scientific and health surveillance activities.

The Director will serve as the senior accountable leader to DOE for program execution, quality assurance, compliance, and continuous improvement. This is a full‑time contractor‑support position located on‑site at DOE offices.

Candidates must be local (or willing to relocate) to Oak Ridge, TN or Washington DC area as this position is onsite.

• Provide strategic direction and day‑to‑day oversight of all STRI and Human Subject Health activities.
• Serve as the primary senior liaison to DOE sponsors and program offices.
• Ensure alignment with DOE mission objectives, regulatory requirements, and performance metrics.
• Lead multidisciplinary teams, including scientists, IRB professionals, epidemiologists, IT specialists, laboratory personnel, and data managers.
• Oversee budgets, staffing plans, subcontractors, and performance reporting.
• Ensure adherence to contract requirements, deliverables, and quality standards.

• Coordinate and execute peer and merit review processes for financial assistance applications and scientific programs.
• Ensure integrity, confidentiality, and objectivity of review processes.
• Guide identification and recruitment of subject matter experts across academia, industry, and national laboratories.
• Document, report, and continuously improve peer review practices.

• Oversee development, maintenance, and improvement of integrated IT systems supporting:
  Application submission and review, Participant management, Data retrieval and reporting, Secure information management.
• Ensure systems meet cybersecurity, privacy, and federal data protection standards.

• Provide oversight of DOE IRB and Human Subjects Working Group (HSWG) support functions.
• Ensure regulatory compliance with human subjects protection requirements.
• Oversee education, communications, meeting coordination, and records management for IRB activities.
• Guide improvements in review systems and governance practices.

• Oversee systematic collection, analysis, and interpretation of worker health and exposure data.
• Provide leadership for long‑term health outcome surveillance of current and former DOE workers.
• Ensure quality and integrity of medical and exposure databases.

• Provide executive oversight of DOE Beryllium Registry electronic reporting, data validation, processing, and loading.
• Oversee Lymphocyte Proliferation Testing (LPT) laboratory operations.
• Manage laboratory quality assurance and regulatory compliance.
• Ensure laboratory operations meet DOE specifications and applicable federal standards.

• Oversee operations of HSRD, Radiation Exposure Monitoring System (REMS), and Comprehensive Epidemiologic Data Resource (CEDR).
• Ensure data quality, confidentiality, and secure storage compliant with DOE requirements.
• Support epidemiologic research and regulatory reporting (e.g., 10 CFR 602.5).

• Ensure compliance with DOE Human Subject Protection policies.
• Federal human subjects regulations (Common Rule).
• Data privacy and security requirements.
• Guide implementation of evolving regulatory and ethical standards.

• Advanced degree required (PhD, DrPH, MD, ScD, or equivalent) in one or more of the following:
  Public…