Principal Clinical Research Scientist Abiomed

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function :

Discovery & Pre-Clinical / Clinical Development

Job Sub Function :

Clinical Development & Research Non-MD

Job Category :

Scientific / Technology

All Job Posting Locations :

Danvers Massachusetts United States of America

Job Description :

Abiomed part of Johnson & Johnsons MedTech is recruiting for a Principal Clinical Research Scientist . Remote work options may be considered on a case-by-case basis and if approved by the Company

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at are looking for a strong leader to support the development and design of Abiomeds 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 Abiomeds 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 required

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

Strong understanding of biostatistics

Strong publication history in peer-reviewed journals

Knowledge of healthcare ethics compliance regulations

Strong work ethic self-motivated team player with strong interpersonal skills

Ability to travel up to 15% (domestic and international) to attend site visits investigator meetings and scientific conferences

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

Required Skills : Preferred Skills :

Clinical Evaluations Corrective and Preventive Action (CAPA) Drug Discovery Development Entrepreneurship Good Clinical Practice (GCP) Leadership Medicines and Device Development and Regulation Presentation Design Regulatory Affairs Management Relationship Building Research Documents Safety-Oriented Scientific Research Strategic Change Study Management Tactical Planning Technical Credibility

The anticipated base pay range for this position is :

$174250 - $235750

Additional Description for Pay Transparency :

Subject to the terms of their respective plans employees and / or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs : medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits : Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth / adoption / foster care of a child Condolence Leave 30 days for an immediate family member : 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience :

Staff IC

Key Skills

Machine Learning,Python,Data Science,AI,R,Research Experience,Sensors,Drug Discovery,Research & Development,Natural Language Processing,Data Analysis Skills,Toxicology Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 174250 - 235750