Abbott
Senior Principal Scientist, Clinical Research
Abbott, Sylmar, California, United States, 91342
Senior Principal Clinical Research Scientist
This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. The Senior Principal Clinical Research Scientist will be viewed as a leader on scientific and medical matters related to clinical trial design, clinical evaluations, risk management, strategy, management, and/or analysis of data. Expert in writing/managing clinical evaluation (plans and reports) or clinical trial protocols, risk master lists, clinical trial registrations and results postings, clinical study project timelines and scientific publications. Leads various study support groups and cross-functional teams in order to develop clinical strategy. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge in order to provide directives to teams as well as study sites. Be able to mentor other clinical scientists within Clinical Research. What You'll Work On Provide scientific leadership to the team, advising on different aspects of clinical evaluations and trial strategies, risk management, design, data analysis, and/or a variety of scenarios for a robust strategy and planning. This position will require significant interactions with cross-functional teams within (Biostatics, RA, Clinical Operations, Data Management, Safety, Science, Clinical Affairs, etc) and outside (R&D, strategic marketing, Clinical R&D, Quality Engineering, Product Performance Group, Risk Management) clinical-regulatory organization, and some interactions with principal investigators in the trials. Responsible for the delivery of the development of clinical evaluation plans or reports, and/or study protocols, the resulting reports and able to lead scientific discussions. Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice. Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Participates in and supports audits. Financial, budgetary, and legal interactions are expected as directed by the manager. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Will perform this job in a quality system environment. Required Qualifications Bachelors Degree in related field OR an equivalent combination of education and work experience Minimum 10 years At least 5 years of clinical trial, risk management, or clinical evaluation experience. Comprehensive knowledge of specified functional area. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business. The base pay for this position is $146,700.00
$293,300.00. In specific locations, the pay range may vary from the range posted.
This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. The Senior Principal Clinical Research Scientist will be viewed as a leader on scientific and medical matters related to clinical trial design, clinical evaluations, risk management, strategy, management, and/or analysis of data. Expert in writing/managing clinical evaluation (plans and reports) or clinical trial protocols, risk master lists, clinical trial registrations and results postings, clinical study project timelines and scientific publications. Leads various study support groups and cross-functional teams in order to develop clinical strategy. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge in order to provide directives to teams as well as study sites. Be able to mentor other clinical scientists within Clinical Research. What You'll Work On Provide scientific leadership to the team, advising on different aspects of clinical evaluations and trial strategies, risk management, design, data analysis, and/or a variety of scenarios for a robust strategy and planning. This position will require significant interactions with cross-functional teams within (Biostatics, RA, Clinical Operations, Data Management, Safety, Science, Clinical Affairs, etc) and outside (R&D, strategic marketing, Clinical R&D, Quality Engineering, Product Performance Group, Risk Management) clinical-regulatory organization, and some interactions with principal investigators in the trials. Responsible for the delivery of the development of clinical evaluation plans or reports, and/or study protocols, the resulting reports and able to lead scientific discussions. Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice. Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Participates in and supports audits. Financial, budgetary, and legal interactions are expected as directed by the manager. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Will perform this job in a quality system environment. Required Qualifications Bachelors Degree in related field OR an equivalent combination of education and work experience Minimum 10 years At least 5 years of clinical trial, risk management, or clinical evaluation experience. Comprehensive knowledge of specified functional area. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business. The base pay for this position is $146,700.00
$293,300.00. In specific locations, the pay range may vary from the range posted.