Clinical Advisor

1. Role Overview

The Clinical Advisor is responsible for driving the company's clinical strategy, evidence generation, and post-market clinical activities to support regulatory compliance, product adoption, and commercial growth of the medical technology portfolio. This role leads clinical studies, manages relationships with healthcare professionals, KOLs, supports cross-functional teams with clinical insights, and ensures safe, effective, and compliant clinical use of the company's products.

2. Key Responsibilities

2.1 Clinical Strategy & Evidence Development

• Develop and execute robust clinical evidence plans for chronic wounds (DFUs, VLUs, pressure injuries), surgical wounds, and burns.
• Identify clinical and evidence gaps to support regulatory submissions, reimbursement strategies, and market acceleration.
• Guide development of clinical claims, value propositions, and health economic evidence (e.g., cost savings, reduction in healing time).

2.2 Clinical Trials & Real-World Evidence (RWE)

• Design, initiate, and manage clinical trials, PMCF programs, registries, and observational studies.
• Lead site selection, ethics/IRB submissions, contracting, start-up activities, and ongoing site monitoring.
• Ensure all clinical activities comply with ISO 14155, GCP, EU MDR, and applicable local regulatory requirements.

2.3 Clinical Education & Field Support

• Train clinicians, wound care specialists, and sales teams on the safe and effective use of company technologies.
• Develop clinical education materials including protocols, user manuals, treatment pathways, and training modules.
• Provide advanced clinical support across hospitals, outpatient clinics, home healthcare, and long-term care facilities.

2.4 Post-Market Surveillance & Safety

• Lead product safety event reporting and follow-up, including adverse event assessment and escalation.
• Develop PMCF plans, support CER inputs, and conduct vigilance activities as required.
• Monitor product performance trends such as infection rates, dressing performance, exudate leakage, and device malfunctions.

2.5 KOL Engagement & Clinical Community Management

• Build and maintain strong relationships with wound care nurses, tissue viability nurses, podiatrists, dermatologists, and key opinion leaders (KOLs).
• Organize advisory boards, clinical roundtables, evaluations, and user feedback forums.
• Support scientific publications, clinical case studies, and conference activities (e.g., EWMA, WoundCon, SAWC).

2.6 Cross-Functional Collaboration

Provide clinical expertise to product development teams for design improvements (adhesion, absorbency, wear time, ergonomics).

• Support Marketing with clinical messaging, claims validation, scientific content, and thought leadership materials.
• Collaborate with Regulatory, Quality, and Commercial teams to ensure clinical alignment across projects.

2.7 Product Development & Clinical Insights

• Translate clinical workflow requirements into product specifications and development priorities.
• Identify unmet needs in chronic wound management, driving innovation and new clinical pathways.
• Participate in formative and summative usability testing to validate product design and user experience.

3. Competencies & Capability Requirements

3.1 Education

• Degree in Medicine, Nursing, Life Sciences, Biomedical Engineering, or a related field.
• Advanced practice wound care certification is strongly preferred (e.g., WOCN, WCN, TVN, CNS with wound care focus).

3.2 Experience

• Minimum 10 years of experience in wound care—clinical, tissue viability, R&D, clinical affairs, or related functions.
• Proven experience designing, managing, or supporting wound care clinical studies.
• Strong understanding of both hospital-based and community wound care workflows and clinical practices.

3.3 Skills & Competencies

• Strong understanding of clinical research methodologies and regulatory frameworks.
• Excellent communication and presentation skills with the ability to train and influence clinical stakeholders.
• Strong analytical, problem-solving, and documentation abilities.
• Ability to work cross-functionally and manage multiple clinical programs simultaneously.
• High degree of professionalism, independence, and strategic thinking.