Senior Medical Director
Smith+Nephew
Summary
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.
Job description
What will you be doing?
- 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.
What will you need to be successful?
- 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%
Education
- 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
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%
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Tuition Reimbursement
- Medical Leave Programs
- Parental Leave
- Paid Time Off
- Paid Holidays
- Volunteer Time
- Wellness Offerings
- Employee Assistance Program
- Discounted Stock Options
- Health Savings Account
- Fertility and Adoption Assistance
Company overview
Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.