Director of Regulatory Affairs

Job ID: req4330
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides support to multiple NIH institutes and divisions, this position will primarily support DCR Office of Clinical Research Policy and Regulatory Operations (OCRPRO) and the National Center for Advancing Translational Sciences (NCATS).

KEY ROLES/RESPONSIBILITIES

• Responsible for directing regulatory staff and managing regulatory activities for the Regulatory Compliance and Human Subjects Protection Program (RCHSPP) within CMRPD, including managing submission of regulatory documents to the FDA and other regulatory authorities.
• Serves as a senior advisor to NCATS, OCRPRO, and NIAID clinical investigators participating in regulatory discussions and activities.
• Provides guidance and leadership for the establishment of regulatory standards and templates for regulatory documents.
• Interacts with clinical investigators, LBR and government team leads and staff to facilitate clinical trials research.
• Provides management oversight of activities conducted by a team of regulatory affairs professionals.
• Reviews documents for content, accuracy, and compliance with applicable regulations prior to submission to regulatory agencies.
• Reviews OCRPRO policies for content, accuracy, and compliance with applicable regulations.
• Reviews clinical trial agreements, transfer of regulatory obligations (TORO) documents, and other clinical and/or regulatory agreements for content, accuracy, and compliance with applicable regulations, NIH and OCRPRO policies.
• Prepares monthly, quarterly, and annual status reports for assigned projects.
• Reviews and approves and/or writes all new or modified SOPs and work instructions to ensure regulatory compliance.
• Provides expert assessments for problem solving utilizing information analysis and regulation research.
• Evaluates regulatory systems, policies and procedures, training programs, and staff to assure continued compliance with regulatory agencies and procedures.
• Evaluates and monitors performance of regulatory staff to meet regulatory requirements, minimize risks, and to comply with SOPs.
• Supervises and mentors a staff of technical personnel.
• Oversees the effective use of available resources and incorporates time management practices to meet established goals and deadlines.
• Prepares, reviews, and manages budgets for RCHSPP Regulatory Affairs group and NCATS projects.
• Develops regulatory presentations and training materials for NIAID investigators, CMRPD staff, and outside researchers.
• Interprets FDA and other regulatory authority policies, procedures and regulations in assigned areas of responsibility.
• This position is on-site Industry Lane/hybrid/local.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a bachelor's degree from an accredited college/university in a field related to biomedical research/clinical trials/health or ten (10) years related experience in lieu of degree. Based on program requirements, certified regulatory, IRB, or clinical research professional preferred.
• In addition to educational requirements, a minimum of ten (10) years directly related experience (industry/pharmaceutical research and development and/or FDA experience) including a minimum of eight plus (8+) years directly managing multiple concurrent clinical projects.
• Foreign degrees must be evaluated for U.S. equivalency.
• Must be detail-oriented and possess strong interpersonal, management, and organizational skills, and the ability to prioritize multiple tasks/projects.
• Must possess excellent written and oral communication skills and clinical trial fieldwork concepts and practices. Must be well versed with a comprehensive working knowledge of FDA regulations and guidelines (CFR, ICH GCP guidelines, international regulations).
• Demonstrated knowledge of data management collection, use of various databases, report compilation for IND submissions, and overall management of regulatory affairs.
• Knowledge of regulatory requirements and guidelines for clinical research.
• Possess solid understanding of the drug development process.
• Ability to provide senior-level leadership in designing, leading, and directing.
• Strong working command of MS Software.
• Possibility of
• Ability to audit and edit written summaries of data for reports, presentations, and/or publications.
• Must be able to obtain and maintain a security clearance.

REQUIRED SKILLS/EXPERIENCE

• In addition to education requirements, a minimum of eight (8) years directly related experience (industry/pharmaceutical research and development and/or FDA experience).
• Must be detail-oriented and possess strong interpersonal, management, and organizational skills, and the ability to prioritize multiple tasks/projects.
• Must possess excellent written and oral communication skills and clinical trial fieldwork concepts and practices.
• Must be well versed with a comprehensive working knowledge of FDA regulations and guidelines (CFR, ICH GCP guidelines, international regulations, inspection readiness).
• Demonstrated knowledge of data management collection, use of various databases and eCTD software, report compilation for IND submissions, and overall management of regulatory affairs.
• Knowledge of regulatory requirements and guidelines for clinical research requirements.
• Possess solid understanding of the drug development process.
• Ability to provide senior-level leadership in designing, leading and directing.
• Strong working command of MS Software.
• Possibility of

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Ability to audit and edit written summaries of data for reports, presentations, and/or publications.

Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, 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.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

160,400.00 - 275,750.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions