Principal, Medical Affairs (Principal Scientist)

Job Description

Principal, Medical Affairs

The principal is responsible for defining, implementing, and maintaining safety and effectiveness (S&E) requirements for both current and future products. This role leads the design, execution, and interpretation of feasibility, clinical, and human factors studies, serving as a key scientific and technical authority across project teams and cross-functional partners including Marketing, Regulatory Affairs, Research & Development, and Quality. The principal identifies, evaluates, and advances new technologies and customer solutions, spanning both traditional and emerging scientific domains. The role also establishes and manages collaborations with internal and external experts (e.g., clinical, academic, regulatory, and industry partners) to support innovation, product development, and business objectives. Additionally, the Principal Scientist generates, synthesizes, and communicates clinical and technical evidence to support innovation strategies, product development, regulatory submissions, and product lifecycle management. For marketed Specimen Acquisition (SA) products, the principal provides ongoing technical expertise, training, troubleshooting support, and competitive insights to ensure continued product performance and customer satisfaction.

Duties and Responsibilities

• Medical Affairs Representation & Strategy
  • Represent Medical Affairs in Specimen Acquisition (SA) innovation, technology development, product development, and lifecycle management.
  • Identify key trends, unmet needs, and help shape strategic direction through engagement with KOLs and industry experts.
• Innovation & Cross-Functional Collaboration
  • Partner with cross-functional teams to identify, evaluate, and advance new opportunities through the innovation process.
  • Provide product, customer, and clinical expertise to support development and business decisions.
• Clinical & Scientific Evidence Generation
  • Design and lead clinical, analytical, and feasibility studies, including commutability and bridging strategies.
  • Develop safety and effectiveness requirements and clinical test plans to support regulatory and marketing needs.
• Data Review & Communication
  • Review and interpret scientific literature, study data, and technical findings.
  • Communicate key insights and recommendations to project teams and leadership.
• Risk Management & Product Assurance
  • Evaluate and manage risks related to design changes, NPD, and vendor/material/manufacturing process changes.
  • Ensure safety, effectiveness, and clinical utility of products, labeling, and promotional materials.
• Product Support & Lifecycle Management
  • Provide clinical support across the product lifecycle, including training, troubleshooting, regulatory input, post-market activities, and publication development.
• Medical Expertise & Leadership
  • Provide leadership in Human Factors Engineering (HFE), HEOR, post-market surveillance, and clinical studies.
  • Act as or liaise with KOLs to inform best practices, standards (e.g., CLSI/IFCC), and clinical insights.

Minimum Requirements

• Master of Science (MS) degree or PhD in a health-related field, such as Biochemistry, Chemistry, Microbiology, Molecular Biology, Nursing, or similar disciplines. Bachelor of Science (BS) with 5 plus years of relevant medical device or pharmaceutical company experience maybe considered.
• 5+ years in either clinical laboratory, clinical research, or related healthcare field experience; experience in a medical device, IVD, or pharmaceutical company is a plus.
• Advanced training or board certification in nursing, clinical chemistry, microbiology, molecular biology, or other specialized clinical laboratory disciplines; relevant experience may substitute for certification

Preferred Qualifications

• A PhD or doctoral degree in a relevant field is desirable
• Knowledge, understanding, and interpretation of FDA regulations, ISO standards, EU MDR/IVDR, and other industry standards for medical devices or similar industry
• Familiarity with BD products
• Professional certification (type not specified, but likely relevant to medical affairs or quality assurance)

Knowledge and Skills

• Scientific, Clinical & Regulatory Expertise
  • Strong knowledge of scientific methodologies and their application in clinical laboratory medicine
  • Solid understanding of clinical study design, execution, data analysis, and interpretation
  • Knowledge of best practice standards and guidelines for specimen management (e.g., CLSI, IFCC)
  • Understanding of MDR, FDA, and global regulatory requirements for medical devices
• Communication & Interpretation
  • Ability to interpret complex clinical and scientific information and communicate it clearly and concisely
  • Strong verbal, written, and presentation skills
• Collaboration & Interpersonal Effectiveness
  • Excellent interpersonal skills, including collaboration, active listening, and conflict resolution
  • Demonstrates empathy and ability to work effectively across cross-functional teams

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. For most roles, 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. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.

• NJ Benefits Disclosure:

At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus

Health and Well-being Benefits

Medical coverage, Health Savings Accounts, Flexible Spending Accounts, Dental coverage, Vision coverage, Hospital Care Insurance, Critical Illness Insurance, Accidental Injury Insurance, Life and AD&D insurance, Short-term disability coverage, Long-term disability insurance, Long-term care with life insurance.

Other Well-being Resources

Anxiety management program, wellness incentives, sleep improvement program, diabetes management program, virtual physical therapy, emotional/mental health support programs, weight management programs, gastrointestinal health program, substance use management program, musculoskeletal surgery, cancer treatment, and bariatric surgery benefit.

Retirement and Financial Well-being

BD 401(k) Plan, BD Deferred Compensation and Restoration Plan, 529 College Savings Plan, financial counseling, Baxter Credit Union (BCU), Daily Pay, college financialaidand application guidance.

Life Balance Programs

Paid time off (PTO), including all required State leaves, educational assistance/tuition reimbursement, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products and services, Academic Achievement Scholarship, Service Recognition Awards, employer matching donation, workplace accommodations.

Other Life Balance Programs

Adoptionassistance, backup day care and eldercare, support for neurodivergent adults, children, and caregivers, caregivingassistancefor elderly and special needs individuals, Employee Assistance Program (EAP), paid parental leave, support for fertility, birthing, postpartum, and age-related hormonal changes.

Leave Programs

Bereavement leaves, Military leave, Personal leave, Family and Medical Leave (FML),Juryand Witness Duty Leave.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit _https://bd.com/careers_.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

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About Us

We are the #MakersofPossible

Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to _advancing the world of health_ ™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

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