BD (Becton, Dickinson and Company) Senior Clinical Project Leader in Franklin Lakes, New Jersey
Job Description Summary
Reporting to the Associate Director, Medical Affairs- Specimen Acquisition and Emerging Specimen Platforms, BD Life Sciences - Integrated Diagnostic Solutions (IDS)- Specimen Management, 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 Senior 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 Senior 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, technical information to support innovation strategies, technology, product development, sustaining engineering and marketed products. In support of all currently marketed IDS products, the Senior CPL provides technical support in the worldwide markets including customer and associate education, troubleshooting, and competitive assessments.
Participates in Specimen Management innovation, technology development, sustaining engineering and product development core teams by sensing and defining key trends and unmet needs in science, technology, medical practice, and health economics. Provides customer and product knowledge to team. Develops safety and efficacy requirements and clinical test plan to address S&E, Regulatory and Marketing requirements for new and improved products and gains functional approval of such. Works with the team to identify and evaluate new opportunities and present such to business leaders following the formal Innovation process. 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 sample management and other related technologies. 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.
Designs 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.
Provides clinical consultation and leadership for HFE studies, HEOR studies, post market surveillance and post market studies.
Scope of Responsibility:
As part of the Specimen Management MA team, this position contributes to the development of the Specimen Management MA strategy relating to innovation and technology development and supports any predefined strategies.
Participates in development of the clinical strategy for all BD Specimen Management products and is responsible for generation of scientific and clinical information to support product conceptualization, feasibility and development.
Responsible for scientific integrity and clinical accuracy of all claims and communications made concerning specific Specimen Management products globally.
Responsible for the safety and efficacy of products released to the market.
Strong knowledge of scientific methodologies and clinical laboratory medicine
Knowledge of sample collection and management techniques
Knowledge of clinical trials and ability to design, review and interpret data from such
Knowledge of the pre-analytical phase of the total laboratory testing process
Excellent interpersonal skills.
Demonstrated leadership skills.
Demonstrated capability for strategic thinking, excellent analytical and problem-solving skills.
Ability to work with global teams and to provide clinical leadership within the IDS business
Ability to integrate medical, scientific, and technical information and effectively communicate these data to the scientific community, customers, as well as throughout the organization.
Ability to network/develop relationships with KOLs from the scientific community
Strong competency in the areas of clinical study design, statistics, technical writing.
Demonstrated ability to understand, interpret and explain complex clinical and scientific information.
Strong communication skills (verbal, presentation, written)
Knowledge of point of care diagnostic testing is desirable
Clinical research experience is desirable
5-7 years of clinical laboratory practice or clinical research; experience in a medical device/IVD company is a plus
Proven understanding of clinical study design and management; Previous clinical trial experience is desirable
Experience interacting with and establishing relationships with KOLs and other scientific leaders is desirable
BS in a health-related field, MS or PhD desirable
Certification: MT(ASCP) or equivalent is desirable
“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.”
Primary Work Location
USA 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, or any other protected status.