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. 

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 Specimen Acquisition (SA) 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 (LSM) 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. Manges 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 (Investigator-Initiated 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:

• Advanced Nursing Degree Required (MSN, DNP, PhD etc.) including direct experience in clinical investigation
• Ability to work onsite 4 days/wk. in Franklin Lakes, NJ
• Minimum of 10 years’ experience in the Medical Device/In Vitro Diagnostics or related industry required
• Minimum of 6 years of experience successfully 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 required
• Experience in infection control highly desired
• 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
• 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. 
• Able to influence directly and indirectly.  Able to initiate and effectively lead change efforts
• Interpersonal Skills - Able to establish and build close working relationships across a highly matrixed organization and with alliance partners.  Strong personal credibility, written and oral communication skills
• Accomplished in group, business and social settings, respected by professional peers
• Comfortable and capable in a variety of cultures and skilled in working internationally
• Business Acumen – Able to demonstrate business acumen in order to effectively manage internal and external relationships and gain credibility in the role
• Leadership Skills - Team oriented with the confidence and integrity to lead and delegate effectively. Self-directed with strong initiative; leads by example. 
• Able to demonstrate the key capabilities of the BD Leadership Standard
• Results and Action Oriented - Driven to excel and capable of inspiring others to excellence as well
• Must be capable and comfortable of decision making based on experience and information at hand. Accepts accountability for results of the MA team and provides clear direction with input from others
• Problem Solving Skills – Brings a high level of intellect and curiosity to work. Able to apply mature business judgment in making decisions with minimal supervision
• Creatively and effectively challenges the thinking of others.  Capable and effective in negotiations
• Able to see the cultural and personal implications of decisions and plan for them
• Willing to travel ~ 15%: U.S., Canada and international
• Must be able to speak and write English fluently; must be able to communicate clearly and accurately
• Must be able to understand legally and technically written standards, regulations, procedures, test methods to communicate their intent
• Manage talent by mentoring direct reports who are nurses/phlebotomists/lab scientists on all technical and business aspects of SA 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.  

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable and learn and improve every day.  

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 people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.   

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

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