Senior Clinical Scientist

The Opportunity

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 (Preferred), Temecula, CA, or New Brighton MN , currently has an onsite opportunity for a Sr.

Research Scientist in the Abbott Vascular Division.

WHAT YOU’LL DO

Responsible for the initiation, design, development, execution, and implementation of scientific research projects.

What You’ll Work On

• Writes clinical trial protocols, protocol amendments, clinical study reports, and scientific publications. by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.

Interacts with regulatory agencies as needed and will use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions.

• Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback / direction.
• Interacts with various study support groups cross-functional teams to assist in clinical strategy, the development of plans, reports and project deliverables.

Is responsible for providing clinical feedback for other cross-functional deliverables.

Facilitates communication between Sales and Marketing, 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, Senior Management and investigational sites as directed by your manager.

Conducts team meetings, drafting and sending routine correspondence (e.g., timelines, meeting minutes) and / or by giving presentations to senior staff on project status.

• 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.
• Participates in and supports audits. May actively participate in root cause analysis. May participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.
• Understands business environment and relates extensive knowledge of internal and external technological activities to trends.
• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Participates in the development of other technical contributors by facilitating training and providing feedback and guidance.

May lead a project team.

• Provides technical leadership to business units, physicians, and oversees and directs external CROs and medical writers.
• Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
• Exercises judgment independently. Plans and organizes project assignments of substantial variety and complexity. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.

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

Preferred Qualifications

• Comprehensive knowledge of a 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
• Works with a strategic mindset to anticipate and creatively solve problems
2 days ago