Director, SM Medical Affairs, Specimen Acquisition Platform

Director Of Medical Affairs

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Reporting directly to the business unit Vice President of Medical Affairs, the Director of Medical Affairs has the responsibility to support the VP, Medical Affairs in providing medical, scientific and technical customer-focused leadership and strategic perspectives across the Specimen Management business unit, as well as acting as the lead medical expert to the Specimen Acquisition platform. This role helps ensure the strategic and operational excellence of the Medical Affairs function that supports new and sustaining products. This individual will be responsible for the management of a team of several Medical Affairs professionals who contribute to product ideation, concept development, product verification, and validation, legal and regulatory compliance, demonstration of product value, and stakeholder education. In addition, this position will have responsibility for supporting technical changes to sustaining products and perform risk / benefit health assessments throughout the product life cycle.

In this role, the Director will partner closely with the SM SA worldwide business team, regional leadership in the Medical Affairs Function, and the Director of Medical Affairs in Lab Specimen Management to align and prioritize product development, product improvement, education, and clinical plans to support SM's value-based strategy. They will oversee the development, update and implementation of the MA Policies and Standard Operating Procedures to optimize MA functioning in terms of leadership, compliance and productivity. The Director, Medical Affairs, will drive the clinical development and evidence generation plans as well as publication and scientific exchange plans to contribute to product development, meet regulatory requirements, and support appropriate product use.

The Director of Medical Affairs needs to have experience in understanding the preanalytical pathway of specimen acquisition and ability to identify technical and logistical barriers in it. This position requires operational experience with product development including clinical trial strategy, design and execution, demonstrated productivity in peer-reviewed publication and public speaking / presentation, as well as external KOL engagement. This position will be a proactive contributor to the business by working closely with R&D, Strategic Marketing, and Business Development to foster innovation within the Business Unit.

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 life cycle management. Ensures understanding and support of BU WW strategy by all MA SA associates.
• Contributes to Business Unit or BDX Medical Affairs KDGs (Key Driver Goals).
• 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.
• Ensures proper study design, analysis, interpretation, and publication / presentation of study results with minimal supervision to maximize value to the business.
• Ensures appropriate input to the product teams for determining the potential clinical utility of any SA product under development by the BU.
• Reviews proposals for IIS Studies and Collaborative Studies.
• Reviews advertising, educational, promotional materials.
• Determination of the safety and efficacy of both new and existing SA products for the BU.
• Reviews Clinical Study Reports and regulatory submissions to ensure adequacy of support for all claims pertaining to the safety, effectiveness, and clinical performance of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed.
• Determining whether adverse health consequences exist for any SA 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 MA support to the worldwide Sales and Marketing departments.
• Builds effective connections, interactions and collaborations with clinical investigators and Key Opinion Leaders (KOLs) at a peer-to-peer level, worldwide.
• Represents BU MA to professional societies and at medical and scientific meetings and seminars.
• Keeps abreast of trends in health care diagnosis, deliver, and treatment of human disease, especially as these relate to the BU's product portfolio.

Qualifications :

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.

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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