Position Overview

Manage all medical safety aspects of MicroVention’s clinical study program and provide cross-functional medical affairs and safety support. Job duties:
  • Lead a team of medical safety professionals in providing all required medical safety support across pre- and post-market clinical studies, including study safety documentation development, adverse events (AE) review, safety investigations, and startup/management of independent safety committees/adjudicators.
  • Partner with clinical study leadership and Clinical/Medical Affairs Management to ensure safety startup activities and pace of events adjudication aligns with timelines and milestones across studies.
  • Manage and support Medical Safety Specialists in the management of all aspects of Clinical Events Committee (CEC), Data Safety Monitoring Board (DSMB), and Clinical Events Adjudicator (CEA) operations, including scope of work (SOW) development, contracting, training, meeting preparation/scheduling/leadership, AE review and triage, reporting, and invoicing.
  • Review and support Medical Safety Specialists in the review of source documentation and clinical safety data provided by investigational centers and synthesize medical narratives for presentation to physician committees and regulatory authorities.
  • Compile and support Medical Safety Specialists in the compilation of site-reported and adjudicated clinical data and generation of related documents and reports.
  • Provide regular updates on the status of safety activities and key findings across studies to study and cross-functional leadership.
  • Track safety findings and metrics across studies and perform periodic review to identify and document trends.
  • Arrange, lead, and participate in cross-functional meetings presenting and reviewing key study safety findings and trends.
  • Drive the selection of physician partners, including CEA, CEC, and DSMB delegates, and other committee members.
  • Draft, review, and provide input to the medical safety components of clinical study protocols, study reports, safety manuals, study supporting materials, and other related documentation.
  • Draft, implement, and ensure compliance with medical safety and medical affairs SOPs and other procedural documents, update per internal and external requirements, and collaborate cross-functionally to ensure alignment with other department procedures.
  • Arrange and assist in internal and external safety audits.
  • Support clinical science and regulatory affairs functions by utilizing/deploying medical expertise to provide input to study design, clinical evaluation reports, clinical study reports, literature review, risk management, regulatory submissions, questions from regulatory authorities, scientific analyses, and other scientific documentation.
  • Support clinical project management function by utilizing/deploying medical expertise to provide input to protocol development, risk/benefit analyses, adverse events review, adverse events reporting, investigator questions, investigator meetings, clinical study reports, and other related documentation/activities.
  • Minimal travel required (1 – 3 trips per year).
  • Perform/lead other medical safety and medical affairs-related duties as assigned.
    1. RN/BSN or equivalent with a minimum of six (6) years of experience in a medical safety function supporting regulated clinical device studies or a combination of relevant clinical research experience, academic experience, and experience in a hospital setting.ORan MD or foreign equivalent with a minimum of one (1) year of experience in a medical safety function supporting regulated clinical device studies or a combination of relevant clinical research experience, academic experience, and experience in a hospital setting.
    2. Minimum of one (1) year of leadership or supervisory responsibility.
    3. Knowledge of GCP, FDA, and ICH regulations and guidelines.
    4. Knowledge and experience in the detection, understanding, review, investigation, and assessment of adverse events.
    5. Ability to produce high-quality scientific communications, presentations, and narratives.
    6. Strong written and verbal communication skills with the ability to present to a small to mid-sized group.
    7. Strong interpersonal skills to build effective relationships with geographically diverse physicians and internal business partners.
    8. Ability to effectively assign and monitor work.
    9. Strong detail-orientation and organizational/time management skills.
    10. Strong leadership skills with the ability to strategically deploy available resources to ensure effective coverage and support across projects.
    11. Proficiency in standard computer programs including MS Office (Word, Excel, PowerPoint, etc.).
    12. Ability to maintain strict confidentiality.
    Desired Qualifications
    1. MD or foreign equivalent.
    2. Clinical, academic, CRO, or industry experience in a relevant field (neurology, neuroradiology, or neurosurgery).
    3. Class III medical device safety experience.