Principal Clinical Research Scientist job at Johnson & Johnson in Danvers, MA

Title: Principal Clinical Research Scientist - AbiomedLocation: Danvers, Massachusetts, United States of AmericaWork Type: Hybrid, Full TimeJob ID: R-046412Job Description: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.Job Function:Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:Clinical Development & Research - Non-MDJob Category:Scientific/TechnologyAll Job Posting Locations:Danvers, Massachusetts, United States of AmericaJob Description:Abiomed, part of Johnson & Johnson's 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 CompanyAt 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. 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 andResponsibilities:Execute on Abiomed's scientific objectives within Abiomed-sponsored clinical studiesServe as scientific lead on Abiomed-sponsored clinical studies, and be the point person for scientific questions during execution of these studiesOwn protocol development, revisions, submission, and approval, including consensus building with study steering committee and principal investigators and communication with FDAWork closely with biostatistics team to evaluate study design options and analyze study data to support study decisions related to protocol development and study executionSupport the production of trial-related interim analyses, hypothesis testing, publications, and presentationsOwn steering committee meetings and serve as scientific lead on investigator/research coordinator meetingsProvide scientific support for development of electronic data capture (EDC) for Abiomed-sponsored clinical studiesResponsible for scientific content for all trial-related documentsOwn annual and final report content development, and coordination of content from various stakeholdersDevelop, 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 proceduresDevelop and execute publication/presentation charters for clinical studiesEnsure data analysis integrity for clinical studies within scope of roleDrive strong publication/presentation cadence for Abiomed sponsored clinical studiesExecute on the regulatory pathway required for new investigational devices and for indication expansion globallyConduct literature review and clinical data review to support regulatory submissions and CERsCross-collaboration with other Medical Office departmentsJobQualifications:Advanced degree in science or engineering; PhD or MD requiredAt least 5 years relevant post-graduate research experienceAt least 3 years clinical science/research experience in cardiology/cardiovascular space or medical devices requiredMedical device and/or industry clinical research experience strongly preferredExperience with scientific contribution to large multicenter clinical trials requiredExcellent communication and collaboration skills, comfortable presenting to company leadership and external key opinion leadersStrong understanding of biostatisticsStrong publication history in peer-reviewed journalsKnowledge of healthcare ethics, compliance regulationsStrong work ethic, self-motivated, team player with strong interpersonal skillsAbility to travel up to 15% (domestic and international) to attend site visits, investigator meetings, and scientific conferencesJohnson & 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. 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 CredibilityThe anticipated base pay range for this position is :$174,250 - $235,750Additional 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 Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's 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 Apply tot his job