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Principal Clinical Research Scientist

Date:  Mar 18, 2023

Danvers, Massachusetts, US

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.


I Am Abiomed | I Am Heart Recovery | Patients First!


Job Responsibilities:

We are looking for a strong leader to support the development and design of Abiomed’s global clinical studies with the focus on sound clinical evidence generation to drive better patient outcomes with the use of Abiomed products. The Principal Clinical Research Scientist will oversee clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be able to directly influence a strong evidence generation engine for Abiomed products.


Primary Duties and Responsibilities:

  • Execute on Abiomed’s scientific objectives within Abiomed-sponsored clinical studies
  • Serve as scientific lead on Abiomed-sponsored clinical studies, and be the point person for scientific questions during execution of these studies
  • Own protocol development, revisions, submission, and approval, including consensus building with study steering committee and principal investigators and communication with FDA
  • Work closely with biostatistics team to evaluate study design options and analyze study data to support study decisions related to protocol development and study execution
  • Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations
  • Own steering committee meetings and serve as scientific lead on investigator/research coordinator meetings
  • Provide scientific support for development of electronic data capture (EDC) for Abiomed-sponsored clinical studies
  • Responsible for scientific content for all trial-related documents
  • Own annual and final report content development, and coordination of content from various stakeholders
  • Develop, maintain, and review periodic study reports - review for outliers, ranges, and potentially problematic data; identify and communicate root causes and suggest possible solutions, document data observations, and follow pre-established processes and procedures
  • Develop and execute publication/presentation charters for clinical studies
  • Ensure data analysis integrity for clinical studies within scope of role
  • Drive strong publication/presentation cadence for Abiomed sponsored clinical studies
  • Execute on the regulatory pathway required for new investigational devices and for indication expansion globally
  • Conduct literature review and clinical data review to support regulatory submissions and CERs
  • Cross-collaboration with other Medical Office departments


Job Qualifications:

  • Advanced degree in science or engineering; PhD or MD required
  • At least 5 years relevant post-graduate research experience
  • At least 3 years clinical science/research experience in cardiology/cardiovascular space or medical devices; medical device and/or industry clinical research experience strongly preferred
  • Experience with scientific contribution to large multicenter clinical trials required
  • Excellent communication and collaboration skills, comfortable presenting to company leadership and external key opinion leaders
  • Proficiency in medical terminology, medical writing, experience with following ICMJE guidelines
  • Strong understanding of biostatistics; ability to use statistical programs such as Matlab, SAS a strong plus
  • Demonstrated publications in high impact factor peer-reviewed journals
  • Knowledge of healthcare ethics, compliance regulations
  • Advanced knowledge of MS Office, Adobe suite
  • Strong work ethic, self-motivated, team player with strong interpersonal skills
  • Ability to travel periodically (domestic and international) to attend investigator meetings and scientific conferences


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. Abiomed maintains a drug-free workplace.