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 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

• 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 regulated healthcare industry

• Prior Medical Affairs experience

• Prior experience in clinical trial design, operations and execution

• Prior experience in clinical site engagement and clinical sample acquisition

• Experience in program management is a plus

• 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 all functions related to clinical trial design and execution: CTMs, CRAs, etc

• Strong organizational skills with ability to build high-performing teams

• This position will require travel up to 30% as needed to support organizational goals

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.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Milpitas 135

Additional Locations

USA CA - San Diego (BDB)

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
$181,400.00 - $326,500.00 USD Annual