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.

Location

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

Core Responsibilities Include:

Executive Leadership & Program Oversight

• 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.

Scientific and Technical Resource Integration (STRI)

Peer & Merit Review Oversight

• 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.

Scientific Infrastructure & IT Systems

• 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.

Institutional Review Board (IRB) & Human Subjects Governance

• 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.

Human Subject Health & Protection Surveillance

Health Surveillance & Epidemiologic Programs

• 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.

Beryllium Registry & Laboratory Operations

• 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.

Human Subject Research Database (HSRD), REMS, and CEDR

• 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).

Regulatory & Policy Implementation

• 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.

Required Qualifications

• Advanced degree required (PhD, DrPH, MD, ScD, or equivalent) in one or more of the following: Public Health, Epidemiology, Biomedical Sciences, Occupational Health, Health Physics, Life Sciences, Scientific Administration.
• 15+ years of progressive leadership experience in: Scientific research administration, Federal research program management, Human subjects research oversight, Occupational health or epidemiology.
• Ability to obtain and maintain a security clearance.
• Demonstrated experience managing peer review systems at a federal or large research organization level.
• Experience overseeing IRB operations or human subjects protection programs.
• Experience managing large health surveillance databases and/or epidemiologic data systems.
• Experience leading laboratory operations subject to federal standards.
• Deep knowledge of: Federal research funding and peer review processes, IRB governance and human subjects regulations (45 CFR 46 / Common Rule), Epidemiologic surveillance methodologies, Occupational health data systems, Laboratory quality assurance systems, Data governance, privacy, and cybersecurity requirements, Understanding of DOE‑specific standards (e.g., Beryllium Registry guidance, DOE data requirements), Familiarity with integrated grant management and review IT systems.
• Proven ability to lead multidisciplinary technical teams.
• Strong executive communication skills (written and oral).
• Experience interfacing with federal sponsors and senior scientific stakeholders.
• Demonstrated ability to improve systems and processes.
• High integrity and commitment to scientific objectivity and data confidentiality.
• Experience managing risk in regulated environments.
• Deliver fully compliant, audit‑ready programs.
• Maintain scientific rigor and integrity in peer review processes.
• Ensure accurate, secure, and timely health surveillance reporting.
• Achieve high DOE customer satisfaction.
• Drive measurable improvements in systems, efficiency, and quality.

Preferred Qualifications

• Experience operating in a federal contracting environment.
• Experience working with DOE, NIH, CDC, DOD, or similar federal agencies.
• Additional credentials in human subjects research oversight or regulatory compliance.
• Experience overseeing both scientific review programs and occupational health surveillance.
• Familiarity with radiation exposure monitoring and epidemiologic research infrastructure.
• Prior responsibility for P&L or large program budgets.

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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