BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all.
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 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 Sr. 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 Senior Clinical Project Leader will be responsible for the following:
Track project performance, specifically to analyze the successful completion of short- and long-term goals
Perform risk management to minimize project risks
Manage changes to the project scope, project schedule and project costs using appropriate verification techniques
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
Demonstrated leadership skills
5+ years of clinical laboratory experience or clinical research
Strong competency in the areas of clinical study design, statistics, technical writing.
Experience in a medical device/IVD company is a plus.
Demonstrated capability for strategic and critical thinking, excellent analytical and problem-solving skills
Knowledge of scientific methodologies and clinical laboratory science.
Excellent interpersonal and communication skills.
Previous clinical trial experience is desirable.
We offer a competitive salary and comprehensive benefits package. For immediate consideration, please apply online at: