Scientific Program Manager (Regulatory Affairs) (51824)

Position Objective: The Scientific Program Manager will provide support to the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH). Duties and Responsibilities: Serve as a regulatory affairs management expert. Responsible for managing an Investigational New Drug (IND) application portfolio of products consisting of vaccines and monoclonal antibodies for compliance with the Food and Drug Administration (FDA) regulations for use of investigational products in humans. 1 Serve as an expert on all regulatory matters concerning the development of vaccines and monoclonal antibodies. This involves strategy, implementation, review processes, submissions and compliance with the FDA, National Institutes of Health (NIH) and international regulatory authority regulations. 2 Provide recommendations to the office Director on optimal strategies to advance candidate products to the clinic. 3 Write and review documentation for compliance with FDA current Good Clinical Practice (cGCP), Good Laboratory Practice (GLP), and/or current Good Manufacturing Practice (cGMP). These documents include, but are not limited to, clinical study protocols, informed consent documents, to ensure test plans encompass all required test elements, data parameters, test objectives, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries. Responsible for the management and quality of the Investigational New Drug (IND) application and amendments throughout its lifecycle which includes writing, reviewing and/or editing the initial IND submission, IND amendments, Investigator Brochures and FDA annual reports. Interact with FDA project managers routinely. Responsible for pre-pre and pre-IND meetings and meeting packages, and responses to FDA queries. Develop standard operating procedures, evaluate emerging regulations and changing regulatory landscape for impacts, provide strategic advice, and communicate with stakeholders which may include recommending applicable education and training to personnel for assurance of regulatory compliance. Serve as liaison between the Office and other components involved in product development. Serve on product development teams as the regulatory expert. Prepare detailed reporting to the Director to ensure Sponsor responsibilities are met. This reporting includes but is not limited to the development of adequate clinical monitoring plans, adherence to the study protocol, product accountability, safety of human subjects, validity of data, and compliance with regulatory requirements. Provide strategic regulatory support and advice to external collaborators (including licensing partners) that are using VRC investigational products, to facilitate advanced development and to ensure VRC Sponsor responsibilities as manufacturer are met. Provide regulatory Intelligence by monitoring, gathering, and analyzing of publicly available and experience-based regulatory information needed to develop a strategy for drug development and risk mitigation. Conduct literature and product reviews to inform product development strategy, reviewing and interpreting scientific and technical information, scientific and technical writing, ensuring compliance with regulatory requirements, study data collection management, and preparation or editing of scientific documents and publications. Manage complex systems for data management and document control; supporting the dissemination of information on vaccine, monoclonal antibody, and other VRC clinical trials and collaborations using VRC products; and responds to related inquiries by sites, sponsors, FDA, and international regulatory agencies. Respond to infectious disease outbreaks and pandemic, emphasizing the urgency and importance the VRC mission. Meet with lab members to present updates Basic Qualifications: Master's degree in Biology or similar field of study Minimum of a Master's degree with at least 8-10 years of experience in regulatory affairs related to the early development of vaccines and therapeutics for human use. Expert knowledge of the relationship of clinical research investigators, regulatory agencies like the FDA, and others in the complex network of oversight responsibilities for the conduct of safe and effective clinical research. Ability to analyze, explain, and apply the relevant regulatory provisions in a wide variety of settings and with diverse audiences in order to advance the research program. Ability to communicate both orally and in writing sufficient to prepare and present highly complex material, often on conflicting issues, for a broad range of participants including senior level Department and agency officials, scientific community groups, and members of the public. The qualified individual must be able to make presentations to a variety of audiences and articulate the policies, initiatives and programs relevant to the activities of the program. Audiences may include individuals from a diverse cultural and/or socioeconomic background. The work covers a diversity of duties requiring the synthesis of knowledge, skills, and experience from different fields such as FDA regulatory management, human subjects protection requirements, strategic planning, administration, policy analysis, oral and written communication, and project management. Demonstrates expertise with Microsoft Office Suite Preferred Qualifications: Ability to communicate effectively, orally and in writing, with non-technical and technical staff Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at View email address on click.appcast.io. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law. This position is contingent upon contract award. GAP Solutions, Inc. (GAPSI)