Senior Clinical Research Scientist

Regulatory Toolkit; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott in Alameda, CA is seeking an experienced clinical affairs professional to organize and conduct evaluations for new products and product improvements. You will serve as the clinical resource on development teams, interacting with R&D, Regulatory Affairs, QA and Marketing to identify user needs and market segments.

The role requires deep clinical knowledge, strong documentation skills for regulatory submissions, and collaboration with biostatistics, data management and external

Qualifications

• Bachelor’s Degree in Biological Science or related field with a minimum of 9 years of related work experience. Master’s Degree is preferred.
• Works in a quality system environment and adheres to governmental regulations.
• Ability to collaborate across R&D, Regulatory Affairs, Quality Assurance and Marketing.

Responsibilities

• Provide clinical knowledge for clinical study protocol development, trial design, analysis and interpretation.
• Create high quality, scientifically sound documents for clinical research and regulatory submissions (e.g., FDA).
• Utilize PubMed and referencing software for literature review and data synthesis.
• Evaluate new product ideas by reviewing literature and summarizing information for decision making.
• Contribute to risk analysis for new or improved devices to identify patient and study risks.
• Develop clinical performance evaluation plans to assess physician acceptance and product performance.

Education

Bachelor’s Degree in Biological Science

Master’s Degree preferred

Job description

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

The Opportunity:

Organize and conduct, or participate in, all performance evaluations for new products, product enhancements, and product process changes. Participate as the clinical resource on product development teams, working with R&D, Regulatory Affairs, Quality Assurance and Marketing in identifying user needs and market segments, and presenting relevant evaluation results as necessary.

What you’ll do:

• Provide clinical knowledge and expertise in clinical study protocol development, clinical trial design, analysis and interpretation
• Solid performance in creating high quality, scientifically sound and medically accurate documents that are clear and focused for clinical research and regulatory agency submissions (such as FDA).
• Expertise with health care and medical communication and effective use of on-line research databases, such as Pubmed, and use of integrated referencing software.
• Evaluates new product ideas and business opportunities by reviewing pertinent literature and other available information, summarizing information and making recommendations to appropriate departments.
• Scientific review and input to CRF development. Excellent collaboration skills with biostatistics and data management.
• Participates in the Risk Analysis process for new or improved devices to ensure that potential risks to patients associated with use of the device and risks to study execution are identified and appropriately analyzed.
• Creates clinical performance evaluation plans to assess physician acceptance and the expected performance of new products by interacting with appropriate personnel, (e.g., physicians, engineers, other clinical coordinators, regulatory affairs).
• Cultivates relationships with internal and external customers, (e.g., consultants and investigators) to continue to grow their expertise in clinical research.
• Writes device Instructions for Use (IFU).
• Provide clinical knowledge, expertise and direction relevant to manufacturing, quality, performance and patient safety during all phases of development of a product or concepts to ensure informed decisions are made in these areas.
• Support product development by contributing clinical knowledge to bench testing, performing in-vitro and /or in-vivo device evaluations and assisting in the development of new test methods to provide a better understanding of device performance.
• Coordinate and conduct post-market clinical evaluations of new product designs or enhancements.
• Participates in Product Action process by performing and documenting a Health Risk Assessment and communicating the assessment to Quality Assurance.

Required Qualifications:

• Bachelor’s Degree in Biological Science or similar with a minimum of 9 years of related work experience with a complete understanding of specified functional area. Master’s Degree is preferred.
• Comprehensive knowledge and application business concepts, procedures and practices.
• Uses in-depth knowledge of business unit functions and cross group dependencies/
  relationships.
• Is recognized as an expert in work group. 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.

The base pay for this position is

$114,000.00 – $228,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Alameda : 2901 Harbor Bay Parkway

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf