Associate Director, Medical Affairs, Specimen Management
Summary
We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of healthâ„¢ 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. About the role: Leads all aspects of a team in SM business unit, guiding compliance, product development, and clinical validation. Key Responsibilities:- Strategic Medical Leadership: Drive medical affairs activities throughout new product development-from concept ideation through commercial launch-ensuring all products meet rigorous safety, efficacy, and regulatory standards.
- Clinical Risk Assessment: Collaborate with the Global Medical Safety team to evaluate potential adverse health consequences for all Life Science Management products through formal risk assessment methodologies (FMEAs, Safety Assessments, Health Hazard Evaluations).
- Coordinate study design, analysis, interpretation, and dissemination of clinical evidence that enhances business value while maintaining scientific integrity.
- Product Development Mentorship: Provide expert clinical input to product teams regarding the potential clinical utility of Specimen Acquisition products under development.
- Research Oversight: Evaluate and approve proposals for Investigator-Initiated Studies and Collaborative Research initiatives.
- Content Excellence: Review educational, promotional, and advertising materials to ensure clinical accuracy and compliance with regulatory standards.
- Work collaboratively with R&D, Marketing, Business Development, and other collaborators to align clinical strategy with business objectives.
- KOL Engagement: Develop and maintain peer-to-peer relationships with clinical investigators and Key Opinion Leaders worldwide to advance scientific exchange and product innovation.
- Offer clinical expertise for regulatory submissions and communicate with FDA and international authorities to support safety, efficiency, and clinical performance claims.
- Global Medical Affairs Support: Ensure comprehensive Medical Affairs support to worldwide Sales and Marketing teams.
- Industry Representation: Serve as the business unit's Medical Affairs representative at professional societies, medical conferences, and scientific meetings.
- Healthcare Trend Analysis: Maintain awareness of emerging trends in healthcare diagnosis, delivery, and treatment methodologies relevant to the business unit's product portfolio
- Clinical Expertise: Comprehensive understanding of regulatory requirements and clinical evidence generation methodologies in the medical device/diagnostics space.
- Leadership Excellence: Proven ability to encourage, develop, and lead high-performing teams toward ambitious goals.
- Communication Skills: Outstanding interpersonal and communication capabilities that encourage productive global collaborations and influence key collaborators.
- Attitude Towards Innovation: Forward-thinking approach with a passion for advancing medical technology and improving patient outcomes.
- Analytical Precision: Meticulous attention to detail combined with strong analytical and problem-solving skills.
- Global Perspective: Ability to understand and navigate diverse healthcare systems and regulatory environments.
- Mobility: Willingness to travel up to 15% domestically and internationally to support global initiatives.
- Advanced Nursing Degree Required: MSN, DNP, PhD, with direct clinical investigation experience.
- Minimum 7 years in the Medical Device/In Vitro Diagnostics industry.
- Minimum 3 years (4 preferred) successfully leading and developing teams.
- Demonstrated expertise in phlebotomy and specimen collection within clinical settings. Experience in infection control highly preferred.
- Comprehensive understanding of medical/clinical practices related to sample collection across various clinical settings and laboratory diagnostics.
- Demonstrated record of supporting successful product submissions to US/EU regulatory authorities.
- Ability to interpret and communicate complex standards, regulations, procedures, and test methods.
- Demonstrated knowledge of product development processes with a track record of successfully bringing new products to market
- Clinical research and KOL expertise preferred
USA NJ - Franklin Lakes 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
$177,700.00 - $293,100.00 USD Annual
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