Director of Clinical Safety

Job ID: req4106

Employee Type: exempt full-time

Division: Clinical Monitoring Research Program

Facility: Telework: US

Location: USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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)/Regulatory Compliance and Human Subjects Protection Program (RCHSPP) provides medical leadership for the safety oversight of study products (e.g., biologics, diagnostics, and other devices) including investigational drug safety, data, and safety monitoring in support of the NIAID, Division of Clinical Research (DCR).

Key Roles/Responsibilities

Responsible for providing medical, ethical, regulatory, operational and scientific leadership and direction pertaining to the oversight of drug and device safety in human subjects research, and data and safety monitoring in clinical trials, and related activities of the RCHSPP.

• In conjunction with operations management, responsible for the management and regulatorily compliant safety oversight of scientific/medical contributions of the RCHSPP Clinical Safety Office and all required pharmacovigilance activities, including conducting and managing the review of draft protocols, informed consents and other protocol documents
• Oversees the collection, processing, inbound reporting, review, analysis, and regulatory outbound reporting of adverse events and serious adverse events, including Unanticipated Problems, safety related Protocol Deviations, and Serious and Unexpected Suspected Adverse Reactions, with particular focus on ensuring the timely and effective detection of, and appropriate response to actual and potential subject safety signals in clinical trials for which the RCHSPP provides oversight and safety related support. Oversees, in general, processes and activities to meet regulatory reporting requirements, including the reconciliation of SAE data for IND annual reports
• Acts, in conjunction with the NIAID DCR Clinical Research Oversight, and leadership of peer RCHSPP teams, as the primary external facing Safety/Pharmacovigilance contact point for Investigators, laboratories, peer RCHSPP teams, LBR and DCR leadership, pharmaceutical partner safety organizations, cooperating network safety teams, DSMBs, and those individuals and networks, nationally and internationally, who are developing or conducting studies under NIAID DCR sponsorship
• Serves, along with Safety Office Medical Monitor colleagues, as authorized by the NIAID DCR and the CROS, as final signatory representative, for protocols submitted for sponsor regulatory review prior to submission to the US FDA and the IRB, and for other critical determinations such as study ‘hold’ and ‘pause’ determinations, decisions on exclusions and inclusions of individual subjects in real time, decisions to adjust enrollment ceilings, decisions to effect subject continuation, discontinuation, and unbinding, Safety Review and Communication Plans for applicable studies, and other activities as indicated
• Serves as consultant to study teams on safety and related compliance matters and approaches and strategies for application to, and communication with oversight bodies including the US FDA, IRBs, and international equivalents, including audits
• Conducts training activities, and produces documentation to set, clarify, disseminate, and help ensure compliance with safety related policies and procedures, including work practices and SOPs and template documents, including protocol safety language templates
• Assesses safety profile and pre-clinical data for novel and re-purposed study interventions, in conjunction with investigators, scientists, pharmaceutical partners, and NIAID leadership, to plan and implement appropriate safety related restrictions and oversight activities for proposed studies
• Provides expertise for developing procedures to capture, manage, and report clinical trial safety data including, but not limited to, serious adverse events, unanticipated problems, lab abnormalities, subject withdrawals due to adverse events, capture of adverse event information and coding, unblinding issues, and Investigator Brochure Package Insert updates, in accordance with regulatory requirements
• Ensures, in conjunction with Regulatory Affairs, compliance with regulatory reporting requirements for safety reporting in domestic and international clinical trials
• Serves as assigned medical monitor, as required, with significant responsibility for safety surveillance, providing medical leadership for the safety oversight of study products (e.g., biologics, diagnostics, and other devices) including investigational drug safety, data, and safety monitoring, and related RCHSPP activities
• As needed or in collaboration with other medical monitors, reviews and interprets clinical data on a real-time basis in collaboration with the Principal Investigator (PI) or Data Management Center, if applicable, to determine the safety of the study product being evaluated
• Oversees planning and management of advisory boards and other scientific committees as required by the protocol (e.g., independent reviews, DSMBs, SMCs, etc)
• Collaborates with senior managers within the CSO operations, CMRP Program Management, Clinical Trials Monitoring (CTM), Regulatory Affairs, and Protocol Navigation Team in the implementation and execution of the RCHSPP activities and deliverables
• Supervises a staff of technical and medical personnel, generally at the doctoral or licensed professional (i.e. RN) level
• This position is located in USA
  
  

Basic Qualifications

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

• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of ten (10) years of progressively responsible experience
• Including four (8) years of experience in a leadership/manager capacity.
• Must have experience in clinical research, medical affairs, academic medicine, or medical practice
• Relevant experience in drug safety within the government, pharmaceutical industry, or academic setting in clinical research
• Possess a strong analytical ability and high professional standards in facilitating the conduct of clinical research and evaluating safety data
• Demonstrated oral and written communication skills, along with presentation and teaching skills
• Working expert knowledge of pharmacovigilance; clinical safety regulations and guidelines, and clinical research trials methodology, design, implementation, and analysis
• Demonstrable knowledge of FDA regulations, ICH GCP guidelines, NIH Standards of Clinical Research, and clinical trials research and management
• Ability to communicate effectively with the Sponsor or designee, clinical study staff; render decisions and policy interpretations; and provide guidance and leadership in the performance of complex planning, coordination, and evaluation of duties for a clinical trial project
• Ability to independently identify problems and effectively offer solutions to problems
• Provide excellent technical skills including the ability to comprehend, integrate, and interpret scientific and medical data from a variety of sources
• Ability to obtain and maintain a security clearance
  

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• Possession of a Doctor of Medicine degree from an accredited college or university
• Post graduate clinical research training
• Ability to present scientific information to both technical and non-technical audiences
• Knowledgeable in computer software packages including Microsoft applications
  
  

Commitment to Diversity

All qualified applicants will receive consideration for employment without regard to sex, race, color, 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.

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