Overview Director, SM Medical Affairs, Specimen Acquisition Platform — BD Nogales Norte. Reporting directly to the business unit Vice President of Medical Affairs, the Director of Medical Affairs supports the VP in providing medical, scientific and technical customer-focused leadership and strategic perspectives across the Specimen Management (SM) business unit and acts as the lead medical expert for the Specimen Acquisition (SA) platform. This role oversees a team of Medical Affairs professionals involved in product ideation, concept development, verification and validation, regulatory compliance, demonstration of product value, and stakeholder education. It also supports technical changes to sustaining products and performs risk/benefit health assessments across the product life cycle. The Director collaborates with the SM SA worldwide business team, regional MA leadership, and the Director of Medical Affairs in Lab Specimen Management to align product development, education, and clinical plans with BD\'s value-based strategy. The role also drives MA policies and SOPs to optimize leadership, compliance and productivity, and leads clinical development and evidence generation plans, including publication and scientific exchange plans.

Learn more about the general tasks related to this opportunity below, as well as required skills.

Understanding the preanalytical pathway of specimen acquisition and identifying technical and logistical barriers are essential. The position requires experience in product development, including clinical trial strategy/design/execution, peer-reviewed publication, public speaking, external KOL engagement, and collaboration with R&D, Strategic Marketing, and Business Development to foster innovation.

Responsibilities Works with the Business Unit Leadership to determine strategy for new product development, prioritization of projects. Manages resources to support new product development and sustaining lifecycle management. Ensures understanding and support of BU WW strategy by all MA SA associates. Contributes to Business Unit or BDX Medical Affairs Key Driver Goals (KDGs). Leads MA activities for new product development in SA, including concept ideation, cross-functional development team interactions, and assessment of clinical evidence requirements to meet regulatory, safety and efficacy criteria and support commercial launch. Ensures proper study design, analysis, interpretation, and publication/presentation of study results with minimal supervision to maximize value to the business. Provides input to product teams on potential clinical utility of SA products under development by the BU. Reviews proposals for Investigator-Initiated Studies (IIS) and Collaborative Studies. Reviews advertising, educational, and promotional materials. Determines safety and efficacy of SA products for the BU. Reviews Clinical Study Reports and regulatory submissions to support claims of safety, effectiveness and clinical performance; provides clinical expertise in submissions and regulatory communications globally as needed. Assess adverse health consequences for SA products during development and after market introduction through formal risk assessment procedures in cooperation with Global Medical Safety. Ensure MA support to worldwide Sales and Marketing departments. Builds relationships with clinical investigators and KOLs globally; represents MA to professional societies and at scientific meetings. Stays informed of healthcare trends related to the BU product portfolio. Qualifications Advanced Nursing Degree Required (MSN, DNP, PhD, etc.) including direct experience in clinical investigation. Ability to work onsite 4 days/week in Franklin Lakes, NJ. Minimum of 10 years’ experience in the Medical Device/In Vitro Diagnostics or related industry. Minimum of 6 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. Experience in infection control highly desired. Knowledge of clinical trial design, statistics, and data analysis; solid understanding of GCP and FDA/ISO requirements for clinical investigation. Record of successful product submissions to US/EU regulatory authorities. Knowledge of product development processes and delivering new products to market. Influencing Skills; able to establish rapport and credibility within a technical environment and with external stakeholders (KOLs). Leadership: able to lead change, build cross-functional relationships, and delegate effectively. Strong interpersonal and communication skills; comfortable working in a matrixed organization and internationally. Business acumen to manage internal and external relationships and gain credibility in the role. Travel approximately 15% (US, Canada and international). Fluent in English (written and spoken) and able to understand legally and technically written standards and procedures. Ability to mentor and manage talent; budget and schedule accountability for MA SA group. Note: For certain roles, BD may require proof of full COVID-19 vaccination. Location-specific testing and accommodations will be considered in accordance with law and BD policies. Why Join Us? A career at BD means joining a team that values your opinions and contributions, encourages authenticity, accountability, and continuous learning. BD aims to help you learn, grow, and thrive while contributing to the future of health. To learn more, visit https://bd.com/careers. BD is an Equal Opportunity/Affirmative Action Employer. We do not discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, sexual orientation, gender identity or expression, genetics, disability, military status, or other protected statuses. Salary and benefits information is provided on the BD Careers site and varies by location and role.

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