Scientific Program Manager (Regulatory Affairs) (51824)

GAP SOLUTIONS INC • Bethesda, MD

9d • $110,000 - $125,000 • Onsite

About The Position

The Scientific Program Manager will provide support to the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH). This role involves serving as a regulatory affairs management expert, responsible for managing an Investigational New Drug (IND) application portfolio of products, including vaccines and monoclonal antibodies, ensuring compliance with Food and Drug Administration (FDA) regulations for investigational product use in humans. The position requires expertise in regulatory matters concerning vaccine and monoclonal antibody development, strategy, implementation, review processes, submissions, and compliance with FDA, NIH, and international regulatory authority regulations. The role also involves providing recommendations to the office Director on advancing candidate products to the clinic, writing and reviewing documentation for cGCP, GLP, and cGMP compliance, and managing the IND application lifecycle. Interaction with FDA project managers, preparation for pre-pre and pre-IND meetings, and responses to FDA queries are key responsibilities. The Scientific Program Manager will also develop standard operating procedures, evaluate emerging regulations, provide strategic advice, and serve as a liaison between the Office and other product development components. This includes preparing detailed reporting to the Director on Sponsor responsibilities, clinical monitoring plans, protocol adherence, product accountability, subject safety, data validity, and regulatory compliance. Strategic regulatory support and advice will be provided to external collaborators, and regulatory intelligence will be gathered and analyzed to inform drug development strategy and risk mitigation. The role involves literature and product reviews, scientific and technical writing, ensuring compliance, managing study data collection, and preparing or editing scientific documents and publications. Management of complex data management and document control systems, supporting information dissemination, and responding to inquiries from various stakeholders are also part of the duties. The position emphasizes the urgency and importance of the VRC mission in responding to infectious disease outbreaks and pandemics.

Requirements

• 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.
• Ability to make presentations to a variety of audiences and articulate the policies, initiatives and programs relevant to the activities of the program.
• 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

Nice To Haves

• 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

Responsibilities

• Serve as a regulatory affairs management expert.
• Manage 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.
• Serve as an expert on all regulatory matters concerning the development of vaccines and monoclonal antibodies, including strategy, implementation, review processes, submissions and compliance with the FDA, National Institutes of Health (NIH) and international regulatory authority regulations.
• Provide recommendations to the office Director on optimal strategies to advance candidate products to the clinic.
• Write and review documentation for compliance with FDA current Good Clinical Practice (cGCP), Good Laboratory Practice (GLP), and/or current Good Manufacturing Practice (cGMP).
• Manage and ensure the quality of the Investigational New Drug (IND) application and amendments throughout its lifecycle, including writing, reviewing and/or editing the initial IND submission, IND amendments, Investigator Brochures and FDA annual reports.
• Interact with FDA project managers routinely.
• Manage 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.
• Recommend 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, including 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.
• Support the dissemination of information on vaccine, monoclonal antibody, and other VRC clinical trials and collaborations using VRC products.
• Respond to 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.

Benefits

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level