Senior Clinical Research Scientist

Overview

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines. We employ over 114,000 colleagues in more than 160 countries.

JOB DESCRIPTION:

This position works out of our Pleasanton, CA location in the Heart Failure division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and live full lives.

Senior Clinical Research Scientist is a member of the Global Clinical Affairs team who provides scientific expertise throughout the development and implementation of clinical evaluations, risk management and/or clinical studies. The scientist collaborates with study support groups and cross-functional teams to assist in clinical and data science, clinical strategy, development of plans and reports, and project deliverables. The scientist also interacts with regulatory agencies as needed and uses scientific and medical knowledge to provide directives to the team and study sites as directed by the manager.

• Writes clinical evaluation plans and reports, study protocols, protocol amendments, informed consents, study reports, risk master lists, and scientific papers for publication by evaluating scientific literature, analyzing data, and staying abreast of current clinical practice.
• Examine data sets and determine the best end-to-end analysis plan to address key scientific questions.
• Analyze data (including defining populations, creating model logic, drawing insights, refining analyses and determining outcomes).
• Present analysis results in a cohesive manner.
• Interpret results in preparation for product applications by evaluating clinical and scientific data and literature, and staying abreast of current clinical practice.
• Present scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings, and regulatory agency meetings.
• Facilitate 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 the manager.
• Participate in the development of clinical strategy and trial design by conducting meetings with appropriate departments and individuals to obtain feedback/direction.
• Create, manage, or participate in clinical study or clinical evaluation timelines and budgets by utilizing project management tools, managing vendors, and ensuring expenditures are within budget.
• Facilitate regulatory submissions and communications by coordinating with Regulatory Affairs during the submission process.
• Participate in and support audits.
• Interface with management on significant matters, often coordinating activity across organizational units, physicians, and external CROs and medical writers.
• Participate in the development of other technical contributors by supporting training and providing feedback and guidance.
• Conduct team meetings, draft routine correspondence, and present regular updates to senior staff.
• May participate in project teams, root cause analysis, preventive or corrective actions, and effectiveness monitoring.
• Mentor less-experienced staff and provide work direction or supervision as needed.
• Exercise judgment independently and plan/organize project assignments of substantial variety and complexity.

• Bachelor's degree in science or engineering, or related discipline
• Minimum 5 years related work experience or an equivalent combination of education and work experience

• Advanced Degree (PhD, MD, etc) + 2 years relevant work experience
• Strong independent data analysis and programming skills (R, SPSS, SAS, Mat Lab, etc.)
• Strong Data Communication and Figure Creation Experience
• Understanding of statistical principles

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