Senior Medical Director

Life Unlimited. At Smith+Neb we design and manufacture technology that takes the limits off living. The Senior Medical Director provides expert medical guidance across the full product life cycle for Smith+Neb's portfolio, with a particular focus on the Advanced Wound Management (AWM) franchise. The role includes medical leadership for device, pharmaceutical, biologic, and combination-product activities, including clinical development, medical monitoring, regulatory strategy, benefit-risk evaluation, and evidence generation.

The Sr. Medical Director delivers medical insights to all relevant functions (Clinical Strategy & Operations, Evidence Evaluation, Quality Affairs, Regulatory Affairs, R&D, Marketing, Market Access, Health Economics) and provides medical safety oversight including safety assessments and benefit-risk evaluations.

• Quality & Compliance:
  Comply with QMS requirements, SOPs, and regulatory standards; support Global Medical Affairs processes; contribute to CAPA activities; responsible for FDA medical strategy and BLA clinical readiness.
• Product Safety:
  Provide medical expertise for adverse events, pharmacovigilance, product complaints, and post-market safety signals; contribute to Health Hazard Evaluations, benefit-risk analyses; participate in safety governance (AEMB, MIMB, SERB); serve as escalation point for regulatory authorities.
• R&D and M&A:
  Provide medical therapeutic area expertise throughout development; contribute medical input to external technology evaluations and due diligence; maintain up-to-date knowledge of clinical trends and competitive landscape.
• Clinical Studies:
  Collaborate on clinical study design; serve as medical authority for sponsored studies; ensure GCP compliance (ISO 14155, ICH E6); provide medical monitoring for pharmaceutical, biologic, device, and combination-product studies.
• Regulatory:
  Support regulatory strategy and submissions including FDA IND processes, clinical development plans, investigator brochures, safety update documents, and BLA-related documentation.

• Minimum 15 years of relevant experience (at least 6 years clinical experience, at least 2 years in medical device/pharma/biotech industry)
• Experience in pharmaceutical or biologic clinical development including medical monitoring
• Good understanding of statistical methods
• Expertise in GCP (ISO 14155), FDA 21 CFR 312, ISO 14971, EU MDR
• Experience with FDA regulatory pathways for pharmaceutical/biologic products including IND submissions and BLA strategy
• Knowledge of scientific publications and technical documentation review
• Strong executive presence; ability to present at senior levels
• Patient-focused mindset
• Effective written and oral communication (scientific and non-scientific audiences)
• Strong organizational and interpersonal skills
• Ability to influence, mentor, and collaborate across cross-functional teams
• Travel up to 10%

• Medical degree required
• Post-Doctoral research preferred
• Board certification or equivalent in wound care, burn care, surgery, dermatology, plastic surgery, critical care, or relevant specialty (strongly preferred)
• Active license to practice medicine in country of residence
• Research doctorate (PhD, Dr. med., or equivalent) preferred

You Unlimited. The anticipated base compensation range for this position is $195,000 - $320,938 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, and geographic location. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.

• medical, dental, and vision coverage
• 401(k)
• tuition reimbursement
• medical leave programs
• par…