Reports To: Senior Vice President, Research & Development
Location: Washington, DC

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and Board of Trustees are committed to developing a diverse, equitable and inclusive team.

Position Summary:

The Sabin Vaccine Institute (Sabin) is seeking a Safety Physician to join its Vaccine Research & Development (R&D) Team. The Safety Physician will serve as a subject matter expert that will assure Sabin’s compliance with pharmacovigilance activities, be involved in clinical trial activities and manage and report adverse events. The ideal candidate must be a board certified, registered clinician, experienced in vaccine development. Initially, Sabin’s R&D projects are focused on prophylactic candidate vaccines to protect against Ebola Sudan and Marburg virus funded by the U.S. Government. Sabin is proactively working to grow its project pipeline as we execute our long-term strategy and develop new project opportunities.

Responsibilities:

Clinical Study/Trial Activities

  • Manage pharmacovigilance aspects of protocols and other documents
  • Reconcile information in pharmacovigilance and clinical research databases
  • Oversee clinical monitoring conducted by CROs under the supervision of the Senior Vice President of R&D for assigned product development programs, including support for design and conduct of clinical trials (i.e., protocol and SAP development, ongoing data review, response to IRB/MoH queries)
  • Provide direction and liaise with clinical operations to ensure successful execution of clinical studies
  • Act as clinical representative on study and development teams and at interdepartmental meetings to discuss progression and execution of clinical programs
  • Draft and/or review clinical study reports and help to manage the presentation of key clinical findings to internal and external stakeholders
  • Support critical interpretation of completed clinical trial results for important Go/No-go decisions and in preparation for submission to relevant regulatory authorities
  • Draft documents for assigned development programs (i.e., briefing books for advisory boards or regulatory meetings, clinical development plans)
  • Contribute to annual product Investigator Brochures updates
  • Research published literature and regulatory documents related to clinical development plans, protocol development and execution and other scientific activities
  • Assess literature and disease background for in-licensing opportunities
  • Support creation of in-house medical training and investigator meeting materials
  • Conduct trainings for internal and/or external study personnel to support ongoing studies (IB, protocol, therapeutic area, etc.)
  • Assist with conceptualization, review and authoring of abstracts, posters and manuscripts to support the product publication plan, and lead effort as appropriate
  • Contribute to scientific, clinical and commercial development of product candidates (both internal and external), including medical and scientific input for due-diligence processes and presentation of key findings

Management of Adverse Events

  • Manage all aspects of adverse events case reports, including evaluating, coding, filing, reviewing data against source documents and assessing case severity for follow up
  • Identify appropriate regulatory agency directions and make case referrals
  • Document regulatory agency requests and develop responses to pharmacovigilance requests
  • Draft safety-profile assessment reports
  • Proactively identify, assess and prevent risks; recommend action based on identified risks

Compliance

  • Monitor pharmacovigilance procedures according to contracts, procedures, regulations, and directives; assure compliance of pharmacovigilance activities
  • Actively participate in the preparation, conduct and monitoring of audits and inspections
  • Provide, manage and document training
  • Advise and inform health professionals regarding product safety
  • Participate in the development and implementation of pharmacovigilance contracts and agreements

Other related duties, as assigned

Requirements:

  • Board certified; registered clinician
  • 14+ years relevant experience, preferably in industry, specifically with pharmacovigilance, clinical research or regulatory affairs
  • Protocol development and clinical trial oversight experience required
  • Expert knowledge of pharmacovigilance practices, including existing legislation, regulations and guidelines
  • Industry experience with study design and conduct and finalization of study reports preferred
  • Knowledge of clinical trial design, biostatistics, clinical pharmacology, pharmacokinetics; familiarity with infectious diseases a plus
  • Demonstrated ability to independently conduct literature reviews and present in-depth scientific analysis of published literature
  • Proven ability to author abstracts and contribute to scientific publications
  • Demonstrated success at holding a dialogue regarding the most current scientific and/or medical thinking
  • Ability to adopt new techniques within the discipline
  • Ability to independently solve routine problems within discipline; exercise independent judgment to determine and recommend a path forward
  • Experience in vaccine or biologics clinical trials a plus
  • Demonstrated ability to operate with purpose, urgency and accuracy in a fast-paced and deadline-driven environment
  • Ability to travel with notice (once travel is permitted)

How to Apply:

To be considered, please submit your cover letter and resume via e-mail to [email protected]. Please be sure to reference “Safety Physician, Research & Development” in the subject line. Your cover letter should: (1) address the reasons for your interest in this position; and, (2) describe the knowledge, skills and abilities you would bring the Sabin Vaccine Institute. No phone calls, please. Only short-listed candidates will be contacted.

Salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package (see https://www.sabin.org/careers/employee-benefits).

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.