Senior Research Scientist

Sr. Research 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.

The Sr. Research Scientist provides scientific expertise throughout the development and implementation of clinical studies. Writes/manages clinical trial protocols, protocol amendments, clinical study reports, clinical trial registrations and results postings, clinical study project timelines and scientific publications. Interacts with various study support groups cross-functional teams in order to assist in clinical strategy, the development of plans, reports and project deliverables. Interacts with regulatory agencies as needed and will use their scientific and medical knowledge in order to provide strategic communication to staff as well as study sites as directed by your manager.

What You'll Work On

• Facilitates development of clinical strategy and trial design by interacting with study PIs, key opinion leaders (KOLs) and collaborating cross functionally with other departments including Global Clinical Operations, Research & Development, Regulatory Affairs, and Biostatistics.
• Writes, study protocols, protocol amendments, informed consents, study reports, scientific presentations and papers for publication by evaluating scientific literature, analyzing scientific data 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.
• Works collaboratively with R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Marketing and Sales, Senior Management and investigational sites.
• Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff.
• Creates, manages, or participates in clinical study timelines, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines.
• Throughout study, when appropriate, works cross functionally with clinical field teams and data management to identify missing data, uses metrics regularly to ensure data completeness.
• May work closely with external groups, such as core laboratories, to assess and interpret data.
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Generate documents to support regulatory submission for product and/or respond to questions from regulatory authorities about existing submission.
• Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
• Participates in and supports audits.
• 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.

Education and Experience You'll Bring

Required Experience

• Bachelor's degree in related field
• Minimum 8 years experience
• Experience in clinical trials, working in a regulated environment.
• Experience in medical and scientific writing.
• Comprehensive knowledge of a particular technological field.

Preferred Experience

• Familiarity with one or more data analysis software (such as Excel, Tableau, Power BI) is highly desirable.
• PhD, MD, PharmD or MSN preferred, or BA/BS with an equivalent combination of education and work experience

The base pay for this position is $86,700.00 $173,300.00. In specific locations, the pay range may vary from the range posted.