Head Of Global Safety

Abiomed Danvers , MA 01923

Posted 1 week ago

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.

  • Advise on:

  • 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.

Job Qualifications:

  • MD Required

  • 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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Department Head

Ocean State Job Lot

Posted 7 days ago

VIEW JOBS 3/15/2019 12:00:00 AM 2019-06-13T00:00 Under the direction of store management, the Department Head performs a range of duties to meet the needs of customers and the business. These duties include merchandising and maintaining the sales and stock room areas of their assigned department(s) according to company policies and procedures. The Department Head also works as part of the store team to perform sales transactions and assist customers on the sales floor. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Protection of company assets * Maintaining OSJL merchandising standards for all assigned areas * Restocking assigned department(s) * Merchandising new items according to company guidelines * Ensuring all OSJL customers receive the best possible service on the sales floor and at the point of sale * Proper handling of all transactions and corresponding documentation * Timely communication to store management of any issues * Proper attention to safety issues (i.e. keeping department neat and safe for customers and employees) * Other duties as required Requirements QUALIFICATION REQUIREMENTS: Qualified applicant must be able to perform essential duties and responsibilities with or without a reasonable accommodation. Qualified applicant must be able to set and operate a ticket gun, cut case merchandise, count money, lift merchandise weighing up to 35 pounds, sign merchandise, display product on shelves and on the sales floor up to 6 feet, and climb up and down ladders. Constant standing, walking, bending, and stooping are required throughout the shift. Qualified applicant also must offer flexibility in scheduling to meet business needs. The requirements listed below are representative of the knowledge, skill and/or ability necessary to perform these duties. TRAINING AND EXPERIENCE: Prior retail merchandising and/or cashier experience preferred. SKILLS REQUIRED: * Excellent customer service skills * Ability to perform multiple tasks with an appropriate level of urgency * Ability to follow instructions * Ability to work productively in a team environment * Must be able to speak and comprehend English. Secondary language a plus Ocean State Job Lot Danvers MA

Head Of Global Safety