BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Principal, Medical Affairs in Franklin Lakes, New Jersey

Job Description Summary

Job Summary

Reporting to the Associate Director, Medical Affairs, the Principal, Medical Affairs has the responsibility to define and implement the safety and efficacy (S&E) requirements for current and proposed products. The position is also responsible for study design and interpretation of results of feasibility and validation clinical and human factors studies. Additionally, the Principal 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 Principal 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, and product development, and product lifecycle management for marketed products. In support of all currently marketed Specimen Management (SM) products, the Principal provides technical support, associate education, troubleshooting, and competitive assessments.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

The Company:

BD (”BD” or the “Company”), one of the largest global medical technology companies in the world, is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The Company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a mission and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD’s long-term strategy is focused on providing leading medical technologies and innovative solutions for their customers and their patients, and driving sustainable healthcare by increasing access, driving better outcomes, mitigating system cost pressures, and improving health care safety, through:

  • Life Sciences: Enhancing the diagnosis of infectious disease and cancer; empowering research insights inside and outside the cell

  • Medical: Improving medication management across the continuum of care; leading in infection prevention and health care safety

  • Interventional: Advancing the management of high burden diseases; enabling surgical and interventional procedures

BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare. In 2017, BD welcomed C. R. Bard and its products into the BD family.

BD Life Sciences Segment / Integrated Diagnostic Solutions (IDS) / Specimen Management Business Group

BD Life Sciences provides products for the safe collection and transport of diagnostics specimens, and instruments as well as reagent systems to detect a broad range of infectious diseases, healthcare-associated infections (“HAIs”) and cancers. In addition, BD Life Sciences produces research and clinical tools that facilitate the study of cells, and the components of cells, to gain a better understanding of normal and disease processes. That information is used to aid the discovery and development of new drugs and vaccines, and to improve the diagnosis and management of diseases. The primary customers served by BD Life Sciences are hospitals, laboratories and clinics; blood banks; healthcare workers; public health agencies; physicians’ office practices; academic and government institutions; and pharmaceutical and biotechnology companies.

The Specimen Management Business Group resides within BD’s Integrated Diagnostic Solutions Business Unit which is located within the BD Life Sciences Segment. The Specimen Management Business Group comprises two business platforms: integrated systems for blood specimen acquisition/ collection (Specimen Acquisition) and integrated systems for blood/urine specimen containment (Lab Specimen Management). BD works in collaboration with healthcare professionals, industry partners and opinion leaders to maintain uncompromising standards of quality, integrity and safety. As the field of diagnostic testing continues to present complex and developing phenomena, BD is assuming a leadership role in the diagnostic industry to ensure the highest level of excellence for their products, services and programs. Since 1943, BD Life Sciences – Specimen Management’s traditions of innovation, customer focus and putting both the healthcare worker and patient first have helped the Company to transform emerging challenges into opportunities for even greater accuracy and product dependability.

Specimen Management’s full range of products includes:

  • BD Vacutainer® blood collection tubes.

  • Safety engineered devices such as the BD Vacutainer® Eclipse™ blood collection needle and BD Vacutainer® Push Button UltraTouch™ blood collection sets, which allow for collection from patients of all types with the added benefit of protecting healthcare workers from the risk of needle stick injuries.

  • BD Microtainer® tubes for pediatric patients and capillary sampling used to collect blood with BD Lancets.

  • BD Vacutainer® urine collection system for the collection and transport of urine samples.

  • BD Vacutainer® blood collection adapters which are compatible with all BD Infusion devices.

  • BD Critical Care Collection syringes including safety products for arterial blood collection and analysis.

  • A novel capillary blood acquisition device and BD Microtainer® tubes

  • A range of Molecular Diagnostic and biomarker products.

Job Summary

Reporting to the Associate Director, Medical Affairs, the Principal, Medical Affairs has the responsibility to define and implement the safety and efficacy (S&E) requirements for current and proposed products. The position is also responsible for study design and interpretation of results of feasibility and validation clinical and human factors studies. Additionally, the Principal 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 Principal 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, and product development, and product lifecycle management for marketed products. In support of all currently marketed Specimen Management (SM) products, the Principal provides technical support, associate education, troubleshooting, and competitive assessments.

Responsibilities

  • Represents Medical Affairs in Specimen Management innovation, technology development, product development and product lifecycle management teams. Senses and defines key trends and unmet needs in science, technology, medical practice, and health economics. Reviews information and assesses risks related to vendor, material and manufacturing process changes. Provides customer and product knowledge to team. 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. 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. Collaborates with Regulatory Affairs on regulatory submission activities.

  • Reviews and interprets medical/scientific data and study results, and technical literature. Monitors trends in specimen management and other related technologies. Communicates findings 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 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 and validation studies related to new technologies and products. Interprets and presents results. Prepares technical reports, abstracts, journal submissions and presents at scientific meetings or within BD.

  • Reviews information and assesses risks related to vendor, material, and manufacturing process changes. Designs clinical studies as needed and interprets and presents results.

  • Provides medical expertise and leadership for post market surveillance and post market studies.

Education and Experience:

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

  • Knowledge of scientific methodologies and clinical laboratory medicine, including specimen collection and management and preanalytical phase of the total laboratory testing process.

  • Knowledge of clinical trials and ability to design, review and interpret data from such.

  • Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.

  • Proficiency in presentation preparation and delivery

  • Strong interpersonal skills - able to establish and build close working relationships across a highly matrixed organization and with alliance partners.

  • Demonstrated leadership skills, ability to deal with ambiguity, quick decision-making, and adaptability to change.

  • Results driven and action oriented; ability to work on fast paced product development teams.

  • Demonstrated ability to prioritize multiple tasks with challenging timelines.

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

  • Ability to work with global teams and to provide clinical leadership within the SM 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 Key Opinion Leaders (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)

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace 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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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

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.

PDN

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

NA (United States of America)

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.

DirectEmployers