Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: "Patients First." With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
The Head of Global Safety, which is a senior leadership role, will report directly to the Chief Medical Officer and is responsible for planning, implementing and executing the safety functions and responsibilities for the clinical research programs and oversight of the post-market safety activities of Abiomed.
Principal Duties and Responsibilities:
Oversees the safety strategy in clinical trials (CTs) and post-marketing (PM) for Impella Platform in the US, EU and Japan.
Work closely with the Global Safety Lead and Chief Medical Officer, based in Danvers, MA, to develop protocols for experimental studies, first in-man investigations and larger multicenter CTs to optimize strategic goals.
Operational leadership: Oversee interface with project management, functional team members, site coordinators and investigators to ensure a timely and precise safety reporting process.
Manage, train and advise the safety team in the US, EU and Japan on all aspects of Safety.
Facilitate talent management activities including hiring, training, staff development and succession planning.
clinical aspects of protocol development for US and EU studies, specifically development of safety elements in the CT protocol, such as, Adverse event (AE) definitions, AE reporting, Risks etc.
site Case Report Form (CRF) development for US and EU studies: specific development of AE reporting form and AE sub-forms, review edit checks, provide feedback into CRF form development.
Data Safety Monitoring Board (DSMB) and Clinical Endpoints Committee (CEC) startup and management activities in US and EU including DSMB/CEC vendor selection/approval, CEC/DSMB member selection, CEC/DSMB charter development, CEC/DSMB conduct during the course of clinical trials to meet timelines and ensuring accuracy.
PM and risk management activities.
Partner with Director of Regulatory to prepare CE Mark, IDE, 510(k), Post-Marketing Authorization (PMA) and related regulatory filings.
Oversee all PM safety-related activities.
Develop training programs and metrics for safety team knowledge, and mentor team members to optimize application of knowledge and performance.
Collaborate with cross-functional teams in Clinical Operations like Biostatistics and Clinical Data Management to provide clinical knowledge and medical guidance as needed.
Oversee conduct of medical assessment on adverse event and/or complaints from multiple clinical studies, including UADE (Unanticipated Adverse Device Effect) determinations, conduct complaint handling assessments, and report adverse events and complaints according to regulatory/company requirements.
Lead monthly signal detection meetings.
Oversee the review and analysis of aggregate safety reports to identify early safety signals and patterns.
Escalate detected signals and patterns to leadership with recommended next steps.
Medical device experience preferred.
Strong clinical knowledge and experience of etiology/pathology of cardiovascular diseases and patient management issues especially coronary artery disease, revascularization procedures, and cardiogenic shock. Significant expertise in reviewing, evaluation and summarizing individual adverse events occurring during the conduct of clinical studies and signal detection and aggregate reporting of adverse events.
Proven prior experience in scientific data interpretation, presentation and publication is required.
Experience in rational/scientific design, study execution, regulatory, compliance, study planning, pertinent patient outcomes, possible adverse events and rational statistical metrics used for validating clinical trials desired.
Skilled in complex project management acquired due to years of experience managing clinical research studies and Health programs.
Strong knowledge of compliance and regulations like Health Insurance Portability and Accountability Act (HIPAA), Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and Good Clinical Practice (GCP).
Excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike.
Self-motivated leader able to manage and motivate research teams, establishing goals; monitoring results to achieve tactical goals.
Proficient with Microsoft Outlook, Word, and Excel; and understanding of database programs is extremely helpful.
Proven ability to work in a multicultural, global environment.
Role will require travels in US and Europe and Japan (~20%) of the time.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.