VP/Director Clinical Operations

VP / Director, Clinical Operations | Clinical-Stage Rare Disease Biotech | United States We are partnering with a growing, clinical-stage biotechnology company focused on developing innovative therapies for patients living with rare diseases. As the company continues to advance its clinical pipeline, it is seeking an experienced VP or Director of Clinical Operations to provide strategic and operational leadership across its global clinical development programs. Reporting to the executive leadership team, this individual will play a key role in driving the execution of clinical studies, building and strengthening the Clinical Operations function, and ensuring the successful delivery of high-quality clinical trials. Key Responsibilities Provide strategic and operational leadership across the company's clinical development programs. Lead the planning, execution, and delivery of global Phase II and Phase III clinical trials. Build, develop, and scale the Clinical Operations function to support pipeline growth. Establish and optimize clinical operational processes, systems, and best practices. Oversee CROs, vendors, and external partners to ensure studies are delivered on time, within budget, and in accordance with quality standards. Partner closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, Quality, and other cross-functional teams. Proactively identify operational risks and implement mitigation strategies to maintain study timelines and quality. Ensure compliance with ICH-GCP guidelines, applicable regulations, and company SOPs. Support clinical development strategy, regulatory submissions, and inspection readiness activities. Provide regular updates on clinical program progress to senior leadership. Recruit, mentor, and develop a high-performing Clinical Operations team as the organization grows. Candidate Profile Significant Clinical Operations leadership experience within the biotechnology or pharmaceutical industry. Proven experience managing global, multi-center clinical trials through Phase II and/or Phase III development. Experience supporting rare disease clinical development programs is highly preferred. Demonstrated success leading Clinical Operations teams within a clinical-stage biotechnology company. Strong experience managing CROs, vendors, and external partners in outsourced or hybrid development models. Thorough understanding of global clinical trial execution, ICH-GCP, regulatory requirements, and inspection readiness. Experience managing study budgets, timelines, and cross-functional project execution. Strong leadership, communication, and stakeholder management skills. Ability to thrive in a fast-paced, collaborative, and evolving biotechnology environment. Hands‑on leadership style with the ability to balance strategic planning and operational execution. This is an exciting opportunity to join a well‑funded, clinical‑stage biotechnology company at an important stage of growth. The successful candidate will have the opportunity to shape the Clinical Operations organization, influence clinical development strategy, and contribute to the advancement of innovative therapies for patients with rare diseases. To learn more or discuss this opportunity confidentially, please apply directly or contact Brad White at HLX Life Sciences. #J-18808-Ljbffr Hlx Life Sciences