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 De