Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), Vaccine Research Center (VRC), Clinical Trials Program (CTP).
Requirements:
-Oversee operational aspects of the VRC Clinical Trials Program (CTP) Pharmacovigilance (PV) Team, which leads the process for safety signal management activities, and ensures the detection, assessment, understanding and prevention of safety events for each investigational product (IP) the VRC manufactures for clinical research.
-Support tactical organization, planning and development for the VRC CTP PV Team as led by CTP Leadership.
-Create and adapt drug safety and pharmacovigilance procedures based on prevailing domestic and international regulations and VRC/NIAID policies and procedures.
-Review safety events for completeness and trends; analyze comprehensive safety data in consultation with PV team; communicate findings per PV Teamwork instructions, SOPs and plans.
-Participate on cross functional, multidisciplinary teams within the CTP/VRC and with external collaborators to plan for regulatory submissions, discuss safety signals and review aggregate safety data.
-Draft, review and finalize PV data sharing agreements with collaborators who receive VRC manufactured investigational products. Ensure timely receipt of PV agreement deliverables.
-Work with VRC's external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).
-Author and provide strategic input and oversight for PV-related sections of periodic regulatory documents (i.e., IND annual reports, DSURs, IB updates) according to the agreed process and timelines.
-Monitor and evaluate safety profiles of VRC manufactured investigational products to detect any change in risk profile.
-Collaborate with CTP protocol operations, clinical and quality and risk management teams, as well as the VRC Regulatory and Strategic Planning groups, to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.
-Perform QC checks of PV Team documents and document repository to ensure completeness and accuracy.
-Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.
-Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.
-Communicate effectively, professionally, and cordially with internal team members and external collaborators with clear, concise, and timely written and verbal communication and presentations.
-Complete and follow up on all assigned tasks in a timely and professional manner.
-Attend all team meetings as requested with punctuality and preparedness.
Qualifications:
-Clinical Advanced degree (NP, PA, MD, DO, etc.) strongly preferred.
-Minimum 5 years' experience in PV or relevant clinical trials experience with significant experience in preparing safety summaries for regulatory documents in a biotechnology, pharmaceutical company, government, or CRO environment.
-Knowledge of clinical trial, drug safety and PV methodologies including safety profile and risk/benefit analysis; detailed comprehension of global regulatory requirements in PV is a plus.
-Experience with MedDRA and drug coding reviews.
-Experience in the conduct and management of clinical trials, phase I - III vaccine or monoclonal antibody clinical trials preferred.
-Strong background in clinical trial drug safety is required.
-An understanding of medical terminology and ability to summarize medical information is required.
-Team lead experience is preferred.
-Strong attention to detail and follow-up skills is required.
-Must be flexible and willing to take on administrative responsibilities to support the PV team, including drafting meeting agendas and note taking, filing documents, scheduling meetings, sending, and tracking requests and reminders to collaborators for data collection.
-Must be proactive and able to create contingency plans to deal with possible challenges and roadblocks.
-Excellent computer and database skills, familiarity with ARGUS platform is preferred.
Visa Sponsorship:

Yes
Agency / Institute:

NIH/NIAID