Senior Medical Director

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

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Flexible Personal/Vacation Time Off

Medical, Dental, Vision

Paid Holidays

Parental Leave

Hybrid Work Model

Job summary

Smith+Naphew seeks a Senior Medical Director to lead medical strategy across the full product life cycle for the AWM portfolio. You will provide medical leadership spanning device, pharmaceutical, biologic, and combination products, guiding regulatory, safety, and evidence generation efforts.

Ideal candidates bring extensive clinical leadership, strong regulatory expertise (FDA, EU MDR), and a passion for advancing patient outcomes through rigorous safety and efficacy assessments.

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.
• 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%.

Responsibilities

• Quality & Compliance: Comply with QMS requirements, SOPs, and regulatory standards; support Global Medical Affairs processes; CAPA activities; FDA medical strategy and BLA readiness.
• Product Safety: Provide medical expertise for adverse events, pharmacovigilance, product complaints, and safety signals; participate in safety governance.
• R&D and M&A: Provide medical input to development; contribute to external evaluations and due diligence; stay updated on clinical trends.
• Clinical Studies: Design collaboration; oversee studies; ensure GCP compliance; provide medical monitoring across study types.
• Regulatory: Support regulatory strategy and submissions including FDA IND processes and BLA documentation.

Skills

Executive presence

Strong communication

Stakeholder mgmt

Regulatory awareness

Education

Medical degree

Board certification

Active medical license

Job description

Life Unlimited

At Smith+Naphew 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+Naphew'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.

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

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. In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.

• Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

• Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Naphew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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