Abbott
Principal Clinical Scientist
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Santa Clara, CA, currently has an opportunity for a Principal Clinical Scientist to join our ONSITE Clinical Science team. What You'll Work On Design clinical trials and studies in collaboration with internal stakeholders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs, medical affairs as well as external stakeholders including steering committees, and national principal investigators to support device premarket approval (PMA) applications and premarket notification submissions (510(k)) to the FDA and strategic business needs. Provides scientific and technical direction and feedback. Provides scientific leadership to Cross Functional and Commercial Teams to support business priorities and serve as Clinical Science lead on study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information. Leads the generation of study-related documents and/or contribute content and oversight of such documents, including, clinical study protocols, case report forms, clinical study reports, and informed consent forms Critically analyze data and present to internal and external groups including but not limited to clinicians and cross-functional team members Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy Lead/collaborate on submission of abstracts, presentations, and publications of clinical study data, working with investigator authors and internal teams Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area Review and critically analyze statistical analysis plans Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions Attend, present at, and leads meetings with FDA and other regulatory bodies Contribute to the optimization of internal processes and workflows Develop new ideas for both external and internal projects Mentor junior team members Performs other related duties and responsibilities, on occasion, as assigned Required Qualifications Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred. Minimum of 8+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience Comprehensive knowledge of a particular technological field 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 Preferred Qualifications Experience in the medical device industry preferred Experience with clinical trials preferred Experience in a vascular/cardiovascular fields a plus The base pay for this position is $112,000.00
$224,000.00 In specific locations, the pay range may vary from the range posted. Job Family:
Research and Discovery Division:
AVD Vascular Location:
United States > Santa Clara : Building B - SC Additional Locations: Work Shift:
Standard Travel:
Yes, 10% of the Time Medical Surveillance:
Not Applicable Significant Work Activities:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Santa Clara, CA, currently has an opportunity for a Principal Clinical Scientist to join our ONSITE Clinical Science team. What You'll Work On Design clinical trials and studies in collaboration with internal stakeholders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs, medical affairs as well as external stakeholders including steering committees, and national principal investigators to support device premarket approval (PMA) applications and premarket notification submissions (510(k)) to the FDA and strategic business needs. Provides scientific and technical direction and feedback. Provides scientific leadership to Cross Functional and Commercial Teams to support business priorities and serve as Clinical Science lead on study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information. Leads the generation of study-related documents and/or contribute content and oversight of such documents, including, clinical study protocols, case report forms, clinical study reports, and informed consent forms Critically analyze data and present to internal and external groups including but not limited to clinicians and cross-functional team members Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy Lead/collaborate on submission of abstracts, presentations, and publications of clinical study data, working with investigator authors and internal teams Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area Review and critically analyze statistical analysis plans Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions Attend, present at, and leads meetings with FDA and other regulatory bodies Contribute to the optimization of internal processes and workflows Develop new ideas for both external and internal projects Mentor junior team members Performs other related duties and responsibilities, on occasion, as assigned Required Qualifications Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred. Minimum of 8+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience Comprehensive knowledge of a particular technological field 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 Preferred Qualifications Experience in the medical device industry preferred Experience with clinical trials preferred Experience in a vascular/cardiovascular fields a plus The base pay for this position is $112,000.00
$224,000.00 In specific locations, the pay range may vary from the range posted. Job Family:
Research and Discovery Division:
AVD Vascular Location:
United States > Santa Clara : Building B - SC Additional Locations: Work Shift:
Standard Travel:
Yes, 10% of the Time Medical Surveillance:
Not Applicable Significant Work Activities:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.