Senior Medical Director

Smith+Nephew•Fort Worth, TX

10d•$195,000 - $320,938•Hybrid

About The Position

The Senior Medical Director provides expert medical guidance across the full product life cycle for Smith+Nephew'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.

Requirements

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%

Nice To Haves

Post-Doctoral research preferred
Board certification or equivalent in wound care, burn care, surgery, dermatology, plastic surgery, critical care, or relevant specialty (strongly preferred)
Research doctorate (PhD, Dr. med., or equivalent) preferred

Responsibilities

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.
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.
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.
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.
Support regulatory strategy and submissions including FDA IND processes, clinical development plans, investigator brochures, safety update documents, and BLA-related documentation.