
Associate Director, Medical Affairs (advanced nursing degree required)
- Franklin Lakes, NJ
- Permanent
- Full-time
- 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.
- Extensive experience 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