Job Description Summary

The BD Biosciences Medical Director 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 developing and validating flow cytometry clinical panels and have a broad understanding of IVD and laboratory developed test (LDT) regulatory environment. By interacting with clinical researchers, laboratory leaders and industry partners, Medical Director will provide product, customer and patient impacting advice and solutions in advanced cell biology, hematology, immune-oncology and other immunologic conditions.

Job Description

The Medical Director will have supervisory responsibilities over the internal medical laboratory and other medical affairs teams.  These teams will contribute to the strategy, evidence generation and post market medical surveillance for BD Biosciences Clinical portfolio of products.  Management of these teams requires technical expertise in next generation flow cytometry panel and LDTs along with depth in laboratory operations and various guidelines and regulations.

Responsibilities:

• Provide leadership for clinical 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 to ensure effective and compliant clinical products and clinical trials to support regulatory and commercial goals
• Develop strategic relationships with key customers to advance the recognition, utility, and supporting evidence of BDB products
• Collaborate with and support internal Clinical Development and Operations teams and Field Facing Medical Affairs functions
• 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
• Provide subject matter expertise into design 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 activities as requested, to identify market gaps, unmet medical needs, and opportunities to support key business objectives
• Provide clinical input to CDx strategy and interacts with external CRO and Pharma/Biotech partners
• Provide subject matter expertise to the organization and serve as a mentor to junior associates

Qualifications:

• Requires an MD or MD/PhD, with specialization in Laboratory Medicine, preference for U.S. trained physician
• Board certification in Hematopathology, with extensive experience and a record of scientific achievements in flow cytometry, cell sorting, and molecular biology is preferred
• Minimum 5-10 years of experience in a diagnostic healthcare environment
• Prior experience in U.S. LDT development
• Deep understanding of regulations pertaining to U.S. LDT and IVD development, IVDR regulatory experience is a plus
• Deep understanding of CLSI guidelines
• Previous experience managing CAP certification/ involvement with other major organizations (Pathology Online, CLSI, ASH, ICCS, NCCN, ASCO, WHO, etc.) 
• Prior experience in clinical trial design, operations and execution
• Experience in program management is a plus
• Excellent command of oral and written communication skills
• Demonstrated ability to work effectively in a large and matrixed organization with multiple stakeholders
• Prior experience in a customer-facing role is a plus

• Proven track record of driving life science innovation as indicated by publications, patents, funding history and new product launches
• Strong communication and presentation skills with an ability to translate complex biological concepts into actionable business options.
• Ability to credibly represent a BD Business or function to external stakeholders, such as business partners, regulatory authorities, and key customers is required
• Possesses a high level of business acumen and organizational savvy, sound professional judgment, and an ability to drive organizational change and serve as a role model within the organization
• Strong interpersonal skills are required. Specifically, cross functional collaboration, listening and negotiation skills are critical
• Experience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites.
• Experience managing clinical flow cytometry laboratory operations and laboratory personnel
• Strong organizational skills with ability to build high-performing teams
• This position will require travel up to 30% as needed to support organizational goals
• Preferred location in Milpitas, CA.  (remote candidates with extensive experience may be considered with regular travel to company location)

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.  

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. We require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.

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. You will work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

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.

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.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Milpitas 135

Additional Locations

Work Shift

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.

Salary Range Information

$163,000.00 - $293,300.00 USD Annual