Senior Medical Director, Wound Care & Med Tech Leadership

Smith & Nephew; Fort Worth (TX); Hybrid; USD 195,000 - 321,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k)

Tuition reimbursement

Medical leave programs

Parental leave

Generous PTO

Paid company holidays

Volunteer time

Wellness programs

Job summary

Smith+Neb is seeking a Senior Medical Director to provide expert medical guidance across the full product life cycle, with emphasis on the Advanced Wound Management portfolio. You will lead medical strategy for device, pharma, biologic and combination products, coordinating with Clinical Strategy, Evidence Evaluation, Quality Affairs, Regulatory, R&D and Marketing.

The role requires 15+ years of experience, medical degree, and active medical license, with travel up to 10%.

Qualifications

• Minimum 15 years of relevant experience (at least 6 years clinical experience, at least 2 years in medical device/pharma/biotech)
• Experience in pharmaceutical or biologic clinical development including medical monitoring
• Strong understanding of regulatory and safety standards (GCP, ISO) and FDA pathways
• Excellent written and oral communication for scientific and non-scientific audiences
• Willingness to travel up to 10%

Responsibilities

• Quality & Compliance: Comply with QMS, SOPs, regulatory standards; support Global Medical Affairs; CAPA activities; FDA strategy and BLA readiness.
• Product Safety: Medical expertise for adverse events, pharmacovigilance, safety signals; governance involvement; escalation to regulators.
• R&D and M&A: Provide medical input across development; due diligence support; monitor clinical trends and competition.
• Clinical Studies: Design collaboration; medical authority for sponsored studies; ensure GCP compliance (ISO 14155, ICH E6).
• Regulatory: Support regulatory strategy and submissions including FDA IND and BLA-related documents.

Job description

Smith+Neb is seeking a Senior Medical Director to provide expert medical guidance across the full product life cycle, with emphasis on the Advanced Wound Management portfolio. You will lead medical strategy for device, pharma, biologic and combination products, coordinating with Clinical Strategy, Evidence Evaluation, Quality Affairs, Regulatory, R&D and Marketing.

The role requires 15+ years of experience, medical degree, and active medical license, with travel up to 10%.