Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Reporting to the Associate Director, Medical Affairs, BD Life Sciences – Integrated Diagnostic Solutions, this position has the responsibility to define and implement the safety and efficacy requirements for current and new 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 IDS 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:

• Develop 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 IDS innovation, technology development and new 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.

EDUCATION:

• BS required, preferably in a health-related field, MS or PhD desirable.

• LICENSES OR CERTIFICATIONS:

  • MT (ASCP) or equivalent is desirable.

MINIMUM QUALIFICATIONS:

• 3-5 years of clinical laboratory experience or clinical research required

• Experience in a medical device/IVD company is a plus.

• Knowledge of scientific methodologies and clinical laboratory science.

• Understanding of clinical studies, study design and study management.

• Excellent interpersonal and communication skills (verbal, presentation, written).

• Demonstrated capability for strategic and critical thinking, excellent analytical and problem-solving skills

• Previous clinical trial experience is desirable

For certain roles at BD, employment sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

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