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.

The Senior Director, Medical Affairs and Clinical Execution will have an extensive background in clinical hematopathology, immunology, cell biology and advanced flow cytometry tools and applications.  In addition, they will have significant experience in clinical operations, clinical trial design and execution and regulatory submissions of diagnostic products. By interacting with clinical researchers, laboratory leaders and industry partners, the Sr. Director, MA will provide product, customer and patient impacting advice and solutions in advanced cell biology, hematology, immune-oncology and other immunologic conditions. 

With a focus on clinical products, the Sr. Director is expected to contribute to the overall business strategy, clinical direction and culture of the organization, working closely with other functions within BD Biosciences, including regulatory affairs, quality, R&D, marketing and commercial functions. This position will help lead the market shaping and market education on the use of high parameter flow cytometry and products in clinical settings for both external and internal customers. They will conduct peer to peer interactions with external key opinion leaders and clinical research groups. They will also collaborate with strategic business and academic institutions, for the purpose of developing and implementing partnerships needed to support the overall business and advance the recognition, utility, and supporting evidence generation of BD Biosciences clinical products. The Sr. Director will have direct supervision over the internal clinical execution, medical affairs and medical laboratory teams.  These combined teams are responsible for clinical development, clinical operations, evidence generation and post market medical surveillance for BD Biosciences Clinical portfolio of products.  Management of these teams requires technical expertise in study design, clinical trial management, monitoring, laboratory operations and US IVD and European IVDR regulations. 

Responsibilities:

• Provide leadership for clinical and research projects in collaboration with both internal and external stakeholders to further BDB business goals and objectives

• Develop and manage the team of laboratory professionals who work in the BDB Medical Laboratory, to ensure timely and productive services as requested or required

• Develop and manage the Medical Affairs and clinical execution team, to ensure effective and compliant clinical products and clinical trials to support regulatory and commercial goals

• Develop and manage clinical trial managers and clinical research associates (monitors) supporting clinical trial execution 

• Develop strategic relationships with key customers to advance the recognition, utility, and supporting evidence of BDB products

• Collaborate with key stakeholders and participate in the Clinical Platforms Program Management to provide clinical and scientific guidance for product development 

• Engage customers to enhance the customer experience and facilitate communication of feedback to enable product improvements

• Provide vital clinical assessment for plans and projects originating within the BDB Platforms

• Drive evidence generation and publication planning for marketing collateral to support clinical products

• Ownership of on-time quality assessments, medical device reporting and health risk assessments to the FDA and other regulatory bodies

• Design and execution of clinical trials for medical device development and submission to the FDA and other regulatory bodies

• Identify and communicate key development goals and strategic initiatives to support the business needs and requirements 

• Participate in business development activit