Global Therapeutic Area Lead, Nephrology

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Provide extensive medical support for designated clinical projects, in line with contractual deliverables and timelines, acting as either the Global Lead Physician or Regional Lead Physician.

• Oversee medical monitoring tasks, which encompass protocol evaluation, development of the Medical Monitoring Plan, and approval of data listings, protocol deviations, and datasets.

• Recognize potential risks, suggest mitigation strategies, and ensure the safety of patients along with the scientific integrity throughout assigned studies.

• Create and review clinical protocols, Medical Monitoring Plans, integrated reports, safety plans, and Informed Consent Forms.

• Cultivate and sustain relationships with clients, address their concerns, and promote enhancements in medical service delivery and client satisfaction.

• Assist in business development activities through proposal crafting, bid pursuit meetings, and conveying Parexel’s medical expertise.

• Maintain advanced knowledge in therapeutic areas via learning opportunities, colleague training, white papers, and publications.

• Offer medical insights for pharmacovigilance workflows and serious adverse event processing, while also supporting regulatory safety reporting.

• Mentor and guide junior team members.

• Engage in departmental and team leadership initiatives.

• Take part in on-call rotations for emergency medical contact and emergency unblinding requests as necessary.

• Utilize performance indicators and metrics to guarantee high-quality and cost-effective medical service delivery.

⛳️ Requirements

• Medical degree (MD, DO, or equivalent) from an accredited medical institution.

• Completion of at least basic clinical training (residency or internship).

• A minimum of 10 years of experience in clinical medicine.

• Specialty in Nephrology.

• Strong foundation in the clinical aspects of drug development, medical monitoring, and study design/execution.

• In-depth understanding of the drug development process, clinical trial regulations, and drug safety.

• Clinical practice experience that showcases medical expertise.

• Familiarity with ICH-GCP, regulatory standards, and clinical trial processes.

• Exceptional verbal and written communication skills in English.

• Strong problem-solving, risk assessment, and decision-making capabilities.

• Board certification in Pharmaceutical Medicine or a related specialty is preferred.

• Experience serving as a Global Lead Physician or Regional Lead Physician in a CRO environment is preferred.

• Background in business development and proposal writing is preferred.

• Experience with CTMS, eTMF, or EDC systems is preferred.

• Understanding of the CRO business model and clinical research operations is preferred.

• Proven track record of mentoring and developing junior medical professionals is 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.