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Job Description Summary

BD Diagnostic Solutions (DS) is seeking an experienced Principal in our Medical Affairs department located in Sparks, MD. This role is accountable for the achievement of key functional business objectives, and oversight of key activities in a platform or program area. Responsibilities include representing Medical Affairs (MA)/Clinical Operations on Core Teams/Product Development Teams for existing and/or new product initiatives and participating in critical product development decisions. The Principal demonstrates understanding of advanced technical/scientific principles applicable to the platform/program area of focus and those of associated disciplines (such as R&D, Regulatory Affairs, Quality, Business, or Project Management). The Principal is recognized as the MA technical subject matter expert across units or functions (for example, product development teams, business/unit or MA leadership teams).

The Principal represents the interest of the patient and the health care worker and has advanced understanding of unmet medical/clinical needs and provides input into product design on behalf of MA and contributes to ongoing evaluations of product safety. The Principal applies expert knowledge of clinical trial design and conduct of highly complex studies when interacting with the extended clinical operations team and is responsible for writing the Medical Affairs Strategy Document as well as the Clinical Trial Plan. The Principal has expert knowledge of local regulations and BD policies and procedures and advanced knowledge of BD products, product development process, ISO standards and elements of design control. The Principal will contribute to regulatory strategies and interactions with US and ex-US regulatory authorities and/or Standards Committees.

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.

BD Diagnostic Solutions (DS) is seeking an experienced Principal in our Medical Affairs department located in Sparks, MD. This role is accountable for the achievement of key functional business objectives, and oversight of key activities in a platform or program area. Responsibilities include representing Medical Affairs (MA)/Clinical Operations on Core Teams/Product Development Teams for existing and/or new product initiatives and participating in critical product development decisions. The Principal demonstrates understanding of advanced technical/scientific principles applicable to the platform/program area of focus and those of associated disciplines (such as R&D, Regulatory Affairs, Quality, Business, or Project Management). The Principal is recognized as the MA technical subject matter authority across units or functions (for example, product development teams, business/unit or MA leadership teams).

The Principal represents the interest of the patient and the health care worker and has advanced understanding of unmet medical/clinical needs and provides input into product design on behalf of MA and contributes to ongoing evaluations of product safety. The Principal applies authoritative knowledge of clinical trial design and conduct of highly complex studies when interacting with the extended clinical operations team and is responsible for writing the Medical Affairs Strategy Document as well as the Clinical Trial Plan. The Principal has authoritative knowledge of local regulations and BD policies and procedures and advanced knowledge of BD products, product development process, ISO standards and elements of design control. The Principal will contribute to regulatory strategies and interactions with US and ex-US regulatory authorities and/or Standards Committees.

Responsibilities also include developing clinical evidence plans to include publication strategies. The Principal will help coordinate and lead the team through journal publications and scientific conference presentations and represent Medical Affairs in market development activities. The Principal will maintain relationships with Key Opinion Leaders and have an advanced understanding of product utility and links to potential patient outcomes.

Additional responsibilities may also include building operational functional excellence in product development and clinical research. The Principal leads MA responsibilities related to Health Risk Assessments by providing relevant medical/clinical input. The Principal possesses critical thinking and analytical skills and can evaluate research by processing complex data to arrive at conclusions.

The Principal may be responsible for indirect leadership of associates, including coaching and feedback. The Principal provides MA oversight and expertise to study teams, extended functional teams or work groups, inspires effective business/function dynamics, and imparts a sense of commitment to business/function goals.

Responsibilities

• Applies extensive technical expertise in a disease/diagnostic area or product/platform and is recognized internally as technical or subject matter authority. Has in-depth knowledge of other related fields such as design control and product development, statistics, and data management. Interprets and describes data.

• Develops and implements clinical plans for projects consisting of multiple studies in support of product design validation and claims. Applies solid knowledge and experience in handling sophisticated projects (possibly including multiple functions & outside partners) and is able to mentor/instruct/interpret and create standard methodologies with respect to tools & processes.

• Handles multiple long-term projects without supervision. Interacts with manager as required by specific issues, landmarks, or status changes. Must have excellent communication skills – in person as well as virtual.

• Formulates short term planning and makes decisions for deliverables and chips in to long-term planning for business/function.

• Develops and maintains relationships with key opinion leaders.

• Develops and implements publication strategies in support of clinical evidence generation plans.

• Builds sophisticated, coherent, professional documentation and correspondence. Prepares formal written reports/documents for distribution within department. Able to present technicsophisticated information at a variety of levels depending upon audience. Confident and credible in discussions among peers, team members and Leaders of Business, and Function. Able to distill findings from high-level /complex discussions and take appropriate action. Work product may require minimal review/input from strategic and technical point of view. Reviews the work of others such as technical, medical, regulatory, and other documents.

• Possesses full knowledge of applicable departmental, business, and corporate policies and procedures. Has operational knowledge of applicable regulations (including international regulations) as they apply to role and responsibilities. Is able to make appropriate functional comments to proposed guidelines and regulations on behalf of Medical Affairs and is able to competently represent MA in regulatory strategies and interactions within BD (early/pre-IDE to submission/registrations), and to regulatory authorities and/or Standards Committees.

• Develops components of a local or functional budget. Plans and budgets resources for complex or multiple projects. May recommend budgets and participates in process of gaining budget approval at function/business level. Carries out, adjusts, and coordinates tasks and activities based on financial and budgetary considerations.

• Independently develops training material requiring little or no review by others. Reviews training materials prepared by others. Trains others to deliver training. Creates and delivers authoritative presentations of sophisticated material to wide-range of audiences, including Senior Management and external partners.

• Anticipates potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses and implements corrective and preventive actions with limited leadership input.

• Identifies process improvement opportunities in own area of responsibility and in related areas. Capable of developing and completing improvement plan for consideration by wider team. Coordinates implementation and tracks/reports metrics.

• Responsible for indirect leadership (including handling achievements, status, issues, and coaching) of study teams or work groups in assigned program area.

• Willingness to travel approximately 10% (domestic and international)

Education/Experience

• Bachelor’s degree required, with preferred education/experience focus in Clinical Microbiology, Molecular Biology, the life sciences, clinical, laboratory or other relevant technical areas. Professional certification (clinical research, laboratory) is a plus.

• Education and experience sufficient to demonstrate shown success as subject matter expert in platform area of focus, or on functional teams across businesses/regions. Experience with IVD clinical trials in particular molecular diagnostics a plus.

• Showed skill in new product development from concept to launch phases required.

• Minimum 3-year experience Medical Affairs, or as a functional Core Team member, or as a clinical project manager, with experience in handling multiple complex or multi-stage projects preferred.

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.

PDN

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

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.