Global Therapeutic Area Lead, Nephrology

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🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Deliver comprehensive medical support for assigned clinical projects, aligned with contracted deliverables and timelines, serving as Global Lead Physician or Regional Lead Physician • Lead medical monitoring activities, including protocol review, Medical Monitoring Plan development, and sign-off on data listings, protocol deviations, and datasets • Identify risks, propose mitigation strategies, and ensure patient safety and scientific integrity across assigned studies • Develop and review clinical protocols, Medical Monitoring Plans, integrated reports, safety plans, and Informed Consent Forms • Build and maintain client relationships, address concerns, and drive improvements in medical service delivery and client satisfaction • Support business development through proposal development, bid pursuit meetings, and communication of Parexel’s medical expertise • Maintain advanced therapeutic-area expertise through learning, colleague training, white papers, and publications • Provide medical input to pharmacovigilance workflows and serious adverse event processing, and support regulatory safety reporting • Mentor and coach junior team members • Participate in departmental and team leadership initiatives • Participate in on-call rotations for emergency medical contact and emergency unblinding requests as applicable • Use performance indicators and metrics to ensure high-quality, cost-effective medical service delivery

🎯 Requirements

• Medical degree (MD, DO, or equivalent) from an accredited medical school • Completion of at least basic clinical training (residency or internship) • Minimum 10 years of experience in clinical medicine • Specialty in Nephrology • Strong background in clinical aspects of drug development, medical monitoring, and study design/execution • Comprehensive knowledge of the drug development process, clinical trial regulations, and drug safety • Clinical practice experience demonstrating medical expertise • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes • Excellent verbal and written English communication skills • Strong problem-solving, risk assessment, and decision-making skills • Board certification in Pharmaceutical Medicine or related specialty preferred • Experience as a Global Lead Physician or Regional Lead Physician in a CRO environment preferred • Business development and proposal development experience preferred • Experience with CTMS, eTMF, or EDC systems preferred • Understanding of the CRO business model and clinical research operations preferred • Track record of mentoring and developing junior medical professionals preferred

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Comprehensive benefits package for eligible employees