Senior Medical Director

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

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.

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.

• 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
• variety of wellness offerings such as EAP

Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving.

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+Neb 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.

We're more than just a company - we're a community!

Smith+Neb is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Neb a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.