Director of Clinical Affairs

Director of Clinical Affairs - Class III Medical Devices

Location: US (hybrid)

Industry: Medical Device (Class III)

Overview

We are seeking a highly experienced and strategic Director of Clinical Affairs to lead global clinical activities for innovative Class III medical devices. This individual will play a critical role in driving clinical strategy, designing and executing pivotal trials, and ensuring alignment with regulatory pathways (e.g., PMA, CE Mark under MDR).

The ideal candidate is a hands-on leader with deep expertise in clinical trial design, regulatory strategy, and cross-functional collaboration, capable of operating in a fast-paced, highly regulated environment. This role requires both strategic oversight and operational execution, with direct influence on product development and commercialization success.

Key Responsibilities

Clinical Strategy & Leadership

• Develop and execute global clinical strategies to support regulatory approval and market access for Class III medical devices.
• Serve as the clinical subject matter expert (SME) for internal and external stakeholders, including executive leadership.
• Lead the design of pivotal and post-market clinical studies, ensuring alignment with regulatory expectations (FDA PMA, EU MDR, other global agencies).
• Provide clinical input into product development, risk management, and labeling claims.

Clinical Trial Execution

• Oversee the end-to-end execution of clinical studies, including:
• Protocol development
• Site selection and feasibility
• Patient recruitment strategies
• Data analysis and interpretation
• Ensure studies are conducted in compliance with GCP, ISO 14155, and applicable regulatory requirements.
• Monitor study progress, proactively addressing risks related to timelines, enrollment, and data quality.

Regulatory & Cross-Functional Collaboration

• Partner closely with Regulatory Affairs to support submissions including PMA, IDE, CERs, and global equivalents.
• Contribute to regulatory strategy discussions, including interactions with FDA, notified bodies, and other health authorities.
• Collaborate with R&D, Quality, Medical Affairs, Biostatistics, and Commercial teams to align clinical evidence with product and business strategy.
• Support advisory boards, investigator meetings, and regulatory agency interactions.

Data & Evidence Generation

• Oversee clinical data generation, ensuring robust, high-quality evidence to support safety and efficacy claims.
• Partner with biostatistics to define statistical analysis plans and endpoints.
• Drive development of clinical evaluation reports (CERs) and publications for peer-reviewed journals and conferences.

Team Leadership & Development

• Build, mentor, and manage a high-performing clinical affairs team, including Clinical Trial Managers and Clinical Scientists.
• Foster a culture of accountability, collaboration, and continuous improvement.
• Manage external vendors, including CROs and clinical consultants.

Qualifications

Education & Experience

• Advanced degree required (MD, PhD, or equivalent preferred) in a relevant scientific or medical discipline.
• Minimum 10-15+ years of clinical affairs experience within the medical device industry.
• Significant experience with Class III devices and pivotal clinical trials.
• Proven track record of supporting successful PMA approvals and/or EU MDR submissions.

Technical Expertise

• Deep understanding of:
• FDA regulations (IDE, PMA) and global clinical requirements
• ISO 14155, GCP, and medical device clinical standards
• Clinical study design (randomized, controlled, real-world evidence)
• Experience working in complex therapeutic areas (e.g., cardiovascular, neuromodulation, structural heart, orthopedics, or similar).

Leadership & Competencies

• Strong leadership skills with the ability to influence cross-functional teams and executive stakeholders.
• Excellent communication and presentation skills, including interactions with regulatory agencies and KOLs.
• Strategic mindset with the ability to translate clinical data into business and regulatory impact.
• Demonstrated ability to thrive in a fast-paced, high-growth environment.

Preferred Qualifications

• Prior experience interacting directly with the FDA (e.g., pre-sub meetings, advisory panels).
• Experience with global clinical programs, including U.S., EU, and APAC regions.
• Background in early feasibility studies (EFS) and first-in-human trials.
• Familiarity with health economics and outcomes research (HEOR) and reimbursement strategy.