Principal Scientist

Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Principal Clinical Research Scientist located in Danvers, MA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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