Description

Biosite-Senior/Principal Clinical Research Scientist



Since the Company was founded in 1988, Biosite Incorporated has been committed to the development of novel, rapid medical diagnostics that improve a physician's ability to diagnose critical diseases and health conditions. Biosite firmly believes this mission and the Company's impressive accomplishments are direct reflections of the talented, bright and creative individuals who contribute daily to its success.

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To build upon this tradition, we are looking for individuals with the drive, motivation and expertise to contribute to a team that looks to solve the biggest healthcare challenges by revolutionizing medical diagnosis. We offer a wide range of employment opportunities for scientists, engineers, chemists, laboratory technicians, and manufacturing workers, as well as staff in marketing, finance, human resources, administrative support, and more.

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Biosite's state-of-the-art research and manufacturing facility is conveniently located in the Sorrento Mesa area of San Diego between the 805 & 15 freeways. Our 350,000 sq. ft. campus was designed for operational optimization and supports an innovative work environment, a work-hard/play-hard philosophy, and cross-departmental communication and collaboration. Among its amenities, Biosite offers its own cafe, a central courtyard with fireplace for gathering with colleagues, onsite gym, soccer field, and volleyball and basketball courts, all to encourage work-life balance for its employees.

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We invite you to explore Biosite further to see for yourself why it's a great place to work.

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Biosite is an Equal Opportunity Employer and values culture and diversity in the workplace.

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EXCELLENT BENEFITS AND WORK ENVIRONMENT!

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Senior/Principal Clinical Research Scientist
Summary

Under minimal supervision, the Senior/Principal Clinical Research Scientist scope of this position is responsible for leading clinical research projects following strategies and tactics formulated in association with R&D project teams and other senior scientific business unit leaders staff to meet department objectives company goals for new product introductions. It is expected that clinical study protocols will be designed, managed and executed in an independent manner and in full compliance with company SOPs and policies, and all applicable regulations leading to definitive, and reliable and timely results.

Tasks and responsibilities:

* Work with multidisciplinary project teams preparing and implementing clinical development plans, study protocols, statistical analysis plans, and clinical study reports and publications.
* Provide clinical research expertise to in support of other R&D, marketing, quality, manufacturing and regulatory affairs departments in some or all of the areas of business interest of the company: cardiology, oncology, womens health, DOA/toxicology, and infectious disease.
* Draft, review and issue. Writes protocols and clinical study reports for clinical studies aimed to validate new products and product claims in support of regulatory submissions worldwide.
* Perform specialized tasks as trained in an independent fashion, requiring minimal ongoing direction. Assist in the establishment of procedures and research methodologies.
* Direct and Provide oversight to investigational sites in the conduct of clinical studies in conjunction with clinical research associates.
* Serve as sponsor representative at scientific meetings and to principal at investigator meetings during which conference calls, study designs and or data are presented and reviewed and data presentations.
* Accompany senior regulatory affairs and clinical staff to FDA meetings as required.
* Complete and review clinical literature searches for the new product evaluation process.
* Develop CRFs that are compatible with the study protocol, the needs of the clinical study staff, and the needs of the data management department.
* Provide recommendations and observations to senior management on study results and progress.
* Learn and apply knowledge of statistical methods to analyze clinical data.
* May supervise staff as required.
* Knowledgeable of federal and other regulations, e.g. QSRs, ISO, ISO 13485, CMDR
* Other responsibilities as assigned.
* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices.
* Willing to travel at least 20% of time if necessary.

Requirements

Preferred educational background:

PharmD, Advanced degree such as a Ph.D. in biology, chemistry or related biomedical field, or M.S in medical technology or nursing is desired. PhD or MS Degree. A Bachelors degree in one of these fields with extensive knowledge and experience and record of accomplishment in clinical research is acceptable. BS is acceptable with extensive knowledge and experience in the area of clinical trials development as it relates to the medical device or in-vitro diagnostics field.

Preferred experiential background:

Extensive knowledge and experience in clinical study design and execution as well as a record of accomplishment in clinical research is required. Strong scientific/medical background so as to write complex study protocols and reports for novel biomarkers is needed and innovative in vitro diagnostic devices. A minimum of 5-10 years experience as a research clinical scientist or clinical research associate is expected with particular skills and knowledge of clinical study design, statistics, good clinical practices, and FDA regulations. regulations with at least 2 years experience in medical or technical writing. Experience in disease diagnosis and management in the fields of cardiovascular, oncology, renal disease and/or infectious disease and/or renal research is strongly desired. Demonstrated skills in carrying out assignments with minimal guidance in an accurate, effective manner. Able to work with a variety of people on multiple tasks. Able to direct staff members if necessary. Strong organizational skills and ability to work on multiple projects simultaneously. Experience in IVD and medical devices industry a plus.

All listed tasks and responsibilities are deemed as essential functions to this position, however, reasonable accommodations will be made if at all possible under business conditions.