Job Description Summary
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.
About the role: Reporting to the VP of Medical Affairs, the Associate Director provides strategic medical, scientific, and technical leadership across the Specimen Management business unit and serves as the lead medical expert for the Specimen Acquisition platform. This role oversees a team supporting product development, compliance, clinical validation, and stakeholder education throughout the product lifecycle.
Leads MA activities of new product development in SA to include concept ideation, interaction with cross functional development teams, and assessment of clinical evidence requirements to meet regulatory, safety and efficacy criteria and support commercial launch.
Determines whether there exist any adverse health consequences for any LSM products that the business manufactures both during development and when marketed, through formal Risk Assessment procedures (FMEAs, SAs, HHEs, etc.) in cooperation with the Global Medical Safety team.
Ensures accurate study design, analysis, interpretation, and publication / presentation of study results with minimal supervision to enhance value to the business.
Ensures appropriate input to the product teams for determining the potential clinical utility of any Specimen Acquisition product under development by the business unit.
Reviews proposals for IIS (Investigator-Initiated Studies) and Collaborative Studies.
Reviews advertising, educational, promotional materials.
Collaborates with cross-functional teams (R&D, Marketing, Business Development)
Builds effective connections, interactions and collaborations with clinical investigators and Key Opinion Leaders (KOLs) at a peer-to-peer level, worldwide.
Reviews all Clinical Study Reports and regulatory submissions to ensure adequacy of support for all claims pertaining to the safety, efficiency, and clinical performance of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed
Determination of the safety and efficacy of both new and existing SA products for the BU.
Assess health impacts of LSM products during development and marketing within collaboration with Global Medical Safety team.
Ensures MA support to the worldwide Sales and Marketing departments.
Represents BU MA to professional societies and at medical and scientific meetings and seminars
Stays ahead of trends in health care diagnosis, deliver, and treatment of human disease, especially as these relate to the BU's product portfolio.
About You: You bring outstanding leadership capabilities to manage and develop a high-performing team. You will bring a consistent track record in clinical trial strategy, design, and execution, along with the ability to effectively navigate and influence within a complex, matrixed organization.
Key Qualifications:
Deep understanding of regulatory requirements and clinical evidence generation.
Strong interpersonal and communication skills to foster global collaboration.
Ambitious and innovative approach with a passion for advancing medical technology.
Exceptional attention to detail and a results-driven approach to problem-solving.
Flawless understanding of regulatory requirements and clinical evidence generation.
Strong interpersonal and communication skills to build relationships globally.
Ambitious drive to innovate and compete in the medical technology field.
Meticulous attention to specifics and an outcome-focused mentality.
Ability to travel up to 15% domestically and internationally.
Education and experience required:
Advanced Degree in Nursing required (MSN, DNP, PhD etc.) including direct experience in clinical investigation.
Minimum of 7 years' experience in the Medical Device/In Vitro Diagnostics industry required.
Minimum of 4 years of experience leading and developing teams.
Global exposure and understanding of medical/clinical practice as it relates to sample collection in various clinical settings and laboratory testing in diagnostics. Experience in phlebotomy and specimen collection in a clinical setting required. Experience in infection control highly preferred
Knowledge of clinical trial design, statistics, and data analysis. Should have a solid understanding of Good Clinical Practices (GCP) and FDA/ISO requirements for clinical investigation. Record of successfully supporting product submission to US/EU regulatory authorities.
Understand legally and technically written standards, regulations, procedures, test methods to communicate their intent
Knowledge of product development processes and a record of delivering new products to market.
Click on Apply if this sounds like you!
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.
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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.
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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics. Our vision for "function or BU" at BD
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under "Our Commitment to You".
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$177,700.00 - $293,100.00 USD Annual
Required Skills
Optional Skills
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Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://jobs.bd.com/benefits) .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$177,700.00 - $293,100.00 USD Annual
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.
