Medline
Sr Dir Medical Affairs
- Location
- Remote (IL)Remote
- Posted
- Posted today (employer shows the date only)
- Source
- Workday (employer's applicant tracking system)
- Category
- Medical Affairs
- Industry
- Medical Device
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Job Summary
Medline is seeking a Senior Director of Medical Affairs to lead the medical and scientific strategy supporting the safe, effective, and appropriate use of our products.
This highly visible leader will shape the future of our Medical Affairs organization, lead Medical Science Liaison teams, and guide clinical evidence generation, scientific communications, clinician education, and medical safety. Working across product divisions and enterprise functions, you will translate clinical insights into decisions that support innovation, patient safety, and business priorities.
Job Description
What You’ll Do
Lead Medical Affairs strategy and evidence generation
- Develop and execute an enterprise Medical Affairs strategy aligned with product, division, and long-term business priorities.
- Provide medical leadership throughout the product life cycle, from clinical development and study design through launch, post-market research, and evidence dissemination.
- Identify evidence gaps and oversee clinical research, outcomes research, real-world evidence, investigator-initiated research, and post-market clinical activities.
- Translate clinical data and stakeholder insights into recommendations for product development, innovation, and risk management.
Build clinical partnerships and lead scientific exchange
- Develop relationships with clinicians, investigators, key opinion leaders (KOLs), professional societies, healthcare organizations, and academic institutions.
- Build and manage KOL networks and clinical and scientific advisory boards.
- Represent Medline at medical congresses, symposia, customer engagements, and clinician education programs.
- Ensure scientific exchange and responses to medical information requests are balanced, evidence-based, and compliant with applicable requirements.
Oversee medical safety and compliance
- Provide leadership for medical safety, vigilance, pharmacovigilance where applicable, benefit-risk assessments, and safety signal evaluation.
- Guide Medical Affairs input into complaint handling, post-market surveillance, Health Hazard Evaluations, and Health Risk Assessments.
- Establish policies, procedures, training, and controls that support compliant Medical Affairs activities.
- Oversee medical review of grants and promotional, educational, and scientific materials.
Guide scientific communications and education
- Set publication strategy and oversee manuscripts, abstracts, posters, white papers, evidence summaries, and other scientific content.
- Lead internal and external education on Medline products and their supporting clinical evidence.
- Chair the Scientific Review Committee and participate in product advisory boards and independent medical education grant committees.
Lead across the organization
- Serve as the senior Medical Affairs partner to Quality, Regulatory, R&D, Clinical, Commercial, Legal, and Compliance.
- Provide independent medical and scientific judgment on product development, labeling, regulatory submissions, safety, and commercialization.
- Lead cross-functional teams through complex medical, scientific, and business issues while maintaining scientific independence.
- Lead and develop Medical Science Liaison teams; define organizational structure, staffing, capabilities, and succession plans.
Required Qualifications
Education and industry experience — one of the following:
- Bachelor’s degree in nursing or a related clinical, scientific, or technical field, plus at least 10 years of medical, scientific, or technical experience in the medical device, biotechnology, or pharmaceutical industry.
- Master’s degree in a clinical, scientific, technical, public health, or related discipline, plus at least 8 years of relevant industry experience.
- MD, DO, PhD, or equivalent doctoral degree, plus at least 5 years of relevant industry experience.
Additional requirements:
- At least 5 years of direct people-management experience, including hiring, developing, and leading employees and leaders.
- Experience in clinical and scientific writing, peer-reviewed publications, and interpreting and communicating complex clinical data.
- Experience supporting product planning, development, publication strategy, scientific materials, and product launches.
- Expertise in Medical Affairs strategy, medical device evidence generation, clinical research, medical safety, and scientific communications.
- Strong understanding of U.S. regulatory and compliance requirements governing Medical Affairs and interactions with healthcare professionals.
- Demonstrated ability to build clinical partnerships, lead cross-functional teams, and communicate effectively with executive, clinical, technical, and customer audiences.
- Strong strategic planning, business acumen, budget management, and organizational leadership skills.
- Commitment to scientific rigor, integrity, accountability, and patient safety.
- Ability and willingness to travel domestically and internationally.
Preferred Qualifications
…
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