BD (Becton, Dickinson and Company) Clinical Project Leader in Franklin Lakes, New Jersey
Job Description Summary
Reporting to the Medical Director, Medical Affairs, BD Life Sciences – Preanalytical Systems, this position has the responsibility to define and implement the safety and efficacy requirements for current and proposed products. The position is also responsible for designing and interpreting results of feasibility, clinical and human factors studies. Additionally, the Clinical Project Leader provides medical, scientific, and technical leadership and perspective to project teams and other functions such as Regulatory and Quality. This position is responsible for identifying, developing and /or evaluating new technologies and customer solutions in scientific disciplines within and outside of the traditional clinical laboratory. The CPL initiates and coordinates liaisons with internal/external medical, academic, regulatory and industry individuals or groups in support of business needs.
The position also generates and communicates clinical and technical information to support innovation strategies, technology development, product development, sustaining engineering and marketed products. In support of all currently marketed PAS products, the CPL provides technical support in the worldwide markets including customer and associate education, troubleshooting, and competitive assessments.
The Clinical Project Leader will be responsible for the following:
Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility.
Designs clinical studies, formulates and conducts scientific investigations, feasibility studies, and due diligence studies related to new technologies and products. Interprets and presents results. Prepares technical reports, abstracts, journal submissions and present at scientific meetings or within BD.
Participates in PAS innovation, technology development and product development core teams by sensing and defining key trends and unmet needs in science, technology, medical practice, and health economics.
Participates in sustaining engineering teams by reviewing information and assessing risks related to material and manufacturing process changes.
Provides customer and product knowledge to team. Identifies appropriate clinical and/or other defined testing to address clinical risks for product changes.
Develops safety and efficacy requirements and a clinical test plan to address S&E, Regulatory and Marketing requirements for new and improved products and gains functional approval of such. With the support of the MA team, ensures safety, efficacy and clinical utility of the product, technology and related labelling/promotional material.
Reviews and interprets medical/scientific data and study results, and technical literature. Monitors trends in laboratory medicine. Communicates findings and interpretations to teams and management.
Interacts with global medical, academic and industry experts to establish strategic direction for innovation, technology and product development projects.
Provides clinical support to products entering or currently on the market including training of customers and BD associates, troubleshooting, data review, interpretation and presentation, post market study design, publications, preparation or review of regulatory communications, and addressing quality issues.
Provides clinical consultation for HFE studies, HEOR studies, post market surveillance and post market studies.
BS required, preferably in a health-related field, MS or PhD desirable.
LICENSES OR CERTIFICATIONS:
MT (ASCP) or equivalent is desirable.
Proven working experience in project management required
1-3 years of clinical laboratory experience or clinical research required
Strong competency in the areas of clinical study design, statistics, technical writing.
Experience in a medical device/IVD company is a plus.
Knowledge of scientific methodologies and clinical laboratory science.
Excellent interpersonal and communication skills.
Previous clinical trial experience is desirable.
Primary Work LocationUSA NJ - Franklin Lakes
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status