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.
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 (SM) business unit, as well as acting as the lead medical expert to the Lab Specimen Management (LSM) segment. The 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 management of the team of 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 LSM worldwide business team, regional leadership in the Medical Affairs Function and the Associate Director of Medical Affairs in Specimen Acquisition to align and prioritize product development, product improvement, education, and clinical study plans to support SM’s value-based strategy. S/he 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 assist the VP, Medical Affairs in establishing and updating the Integrated Medical Plan and driving 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 use.
The Director of Medical Affairs needs to have strong strategic and 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.

QUALIFICATIONS:

• Advanced Degree (PhD, M.D., D.O. or equivalent) required including experience in clinical investigation
• Minimum of 10 years experience in the Medical Device/In Vitro Diagnostics industry required. More than six (6) years of experience leading and developing high functioning teams
• Global exposure and understanding of medical/clinical practice as it relates to sample collection in a variety of clinical setting and laboratory testing in diagnostics. Knowledge of infection control preferred
• Prior experience supervising a clinical laboratory and phlebotomy staff will be an advantage
• Needs 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
• Needs knowledge of product development processes and a record of delivering new products to market
• Influencing Skills - Able to establish rapport, value and respect within a complex and highly technical environment internally, as well as with KOLs and other influential stakeholders, externally
• Interpersonal Skills - Able to establish and build close working relationships across a highly matrixed organization and with alliance partners
• Business Acumen – Able to demonstrate business acumen and maturity in order to effectively manage internal and external relationships and gain credibility in the role
• Leadership Skills - Team oriented with the confidence, maturity and integrity to lead and delegate effectively
• Results and Action Oriented - Driven to excel and capable of inspiring others to excellence as well
• Problem Solving Skills – Brings a high level of intellect and curiosity to work, able to apply mature business judgment in making decisions, creatively and effectively challenges the thinking of others
• Willing to travel ~ 15%: U.S., Canada and international
• Must be able to understand legally and technically written standards, regulations, procedures, test methods to communicate their intent
• Manage talent by mentoring scientists on all technical and business aspects of LSM products
• Budget and schedule accountability for group
  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.

• Works with the Business Unit Leadership to determine strategy for new product development, prioritization of projects. Manges resources to support new product development and sustaining life cycle management
• Ensures understanding and support of BU WW strategy by all MA LSM associates
• May lead, and always contributes to, Business Unit or BDX Medical Affairs KDGs (Key Driver Goals)
• Leads MA activities of new product development in LSM 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 to maximize value to the business
• Ensures appropriate input to the product teams for determining the potential clinical utility of any LSM product under development by the BU
• Reviews and approves proposals for IIS (Investigator-Initiated Studies) and Collaborative Studies
• Reviews and approves advertising, educational, promotional materials.
• Determination of the safety and efficacy of both new and existing LSM products for the BU
• Reviews all 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 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
• Works in close association with R&D and any research or other business groups involved with the exploration of potential new technologies for both core and novel products/services
• 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