Abbott Sr Scientist, Clinical Research in Plano, Texas
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Primary Job Function:
Provides scientific expertise throughout development, execution and reporting of clinical studies.
Applies knowledge of implanted medical device therapies to develop clinical trial protocols, protocol amendments, trial registrations and results postings, clinical study project timelines and scientific publications.
Interacts with cross-functional teams to help develop clinical strategy, study plans, reports and deliverables.
Interacts with regulatory agencies as needed, and will use scientific and medical knowledge to provide directives to colleagues and study sites with limited direction.
Core Job Responsibilities:
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 scientific data and staying abreast of current clinical practice.
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 the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback and direction.
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 collaborating with Regulatory Affairs during the submission process.
Creates, manages or participates in clinical evaluation 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.
Facilitates communication between Sales and Marketing, R&D, Clinical, Regulatory Affairs, Quality, Risk Management, Project Management and investigational sites.
Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and presenting regular updates to senior staff.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Participates in and supports audits. May participate in root cause analysis, preventive or corrective actions and effectiveness monitoring.
Position Accountability / Scope:
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.
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 external partners.
May act as a mentor to less-experienced staff and provide work direction or supervise other technical employees.
Exercises judgment independently.
Plans and organizes project assignments of moderate variety and complexity.
Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
Will perform this job in a quality system environment.
Advanced degree in sciences, engineering, medicine or similar discipline required. Expertise in one or more of the following required: deep brain stimulation, movement disorders, neuroscience, neuroimaging, brain-machine interface.
Minimum of 5+ years of related work experience required, or an equivalent combination of advanced education, research and work experience.
Experience with clinical trials, including IDE, PMCF or feasibility studies strongly desired.
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
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org