Director, MedTech General Surgery Clinical Affairs

Director, Med Tech General Surgery Clinical Affairs

Washington, United States of America | Full time | Home-based | R1541717

The Clinical Director, General Surgery, is a senior clinical leadership role responsible for the scientific, regulatory, and operational oversight of general surgery therapy clinical trials conducted by IQVIA Med Tech. This position provides specialized general surgery subject‑matter expertise, sponsor‑facing leadership, and accountable clinical direction across the full lifecycle of surgical clinical programs. The current area of focus will be robotics, oncology and breast reconstruction, but with the goal of quickly expanding and growing with our integrated services.

The Clinical Director plays a critical role in expanding IQVIA’s general surgery CRO capabilities by ensuring studies are executed in compliance with GCP, applicable regulations, SOPs, and evolving regulatory and clinical expectations for surgical and device‑enabled therapies. The role is both strategic and hands‑on, supporting client delivery, business development, and long‑term practice growth.

• Provide senior clinical leadership for general surgery clinical trials, including feasibility, execution, and closeout.
• Ensure clinical strategy, study design, and execution are appropriate for surgical therapies, implantable devices, procedural technologies, intended use, and regulatory pathways.
• Oversee protocol development, clinical plans, and study documentation for accuracy, completeness, and regulatory compliance.
• Serve as an escalation point for clinical, safety, and quality issues across general surgery studies.

• Act as the primary clinical point of contact for sponsors on assigned general surgery programs.
• Review and approve clinical reports, study communications, and sponsor deliverables.
• Provide clear, data‑driven clinical updates and respond to sponsor questions and concerns.
• Build and maintain strong relationships with sponsors, investigators, and clinical sites, including high‑acuity surgical centers and specialty programs.

• Ensure general surgery studies are properly resourced, executed on time, and managed within budget.
• Ensure adherence to GCP, IQVIA SOPs, and surgical therapy–specific regulatory and quality requirements.
• Collaborate with Clinical Quality Assurance on vendor selection, oversight, audits, and inspection readiness.
• Drive consistency across study execution, documentation standards, procedural training, and investigator onboarding.

• Provide direct leadership, mentorship, and professional development to Project Managers, CRAs, and CTAs supporting general surgery programs.
• Identify departmental training needs related to general surgery clinical trials and ensure implementation.
• Support hiring, onboarding, performance management, and succession planning within the general surgery clinical team.

• Collaborate with IQVIA Med Tech and related business units on general surgery–focused business development, including proposals and bid defenses.
• Provide subject‑matter expertise to support new client opportunities and service expansion in general surgery therapies.
• Contribute to the development and evolution of IQVIA’s surgical clinical service offerings, with emphasis on breast reconstruction, oncology‑driven surgery, and robotic‑assisted procedures.

• Serve as a clinical project lead on general surgery programs as needed, particularly for early‑stage or high‑complexity studies.
• Support cross‑functional alignment across Clinical Operations, Regulatory, Quality, and Biostatistics.

• Bachelor’s degree in a healthcare, life sciences, or related discipline required.
• 7–10+ years of experience in clinical research, with at least 5 years of direct experience supporting general surgery or surgical therapy clinical trials.
• Minimum of 4 years of people leadership or supervisory experience in a CRO or clinical research environment.
• Demonstrated experience…