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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.About ParexelParexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.About the RoleWe are seeking a Senior Medical Director/Therapeutic Area Lead, Nephrology to join our team. As a Therapeutic Area Lead, you will drive clinical excellence and medical oversight across complex clinical trials, ensuring patient safety, regulatory compliance, and scientific integrity. This position plays a key role in study execution, medical monitoring, regulatory strategy, and clinical data accuracy. You'll collaborate with cross-functional teams, sponsor partners, and research sites to deliver world-class medical support from protocol development through study closeout. Responsibilities include medical monitoring leadership, protocol development support, safety oversight, and client relationship management, with opportunities to deepen your expertise in therapeutic areas and influence study outcomes across a diverse portfolio.You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing new treatments, ensuring clinical trial integrity, and delivering exceptional client partnerships. With diverse teams and continuous learning opportunities, the Therapeutic Area Lead can explore career paths and expand skills across clinical research, medical strategy, and team leadership.Key ResponsibilitiesIndependently deliver comprehensive medical support for assigned clinical projects, ensuring alignment with contracted deliverables and timelines while serving as either Global Lead Physician or Regional Lead PhysicianLead medical monitoring activities including protocol review, Medical Monitoring Plan development, and sign-off on data listings, protocol deviations, and datasets for medical accuracy and consistencyProvide strategic medical leadership by identifying risks, proposing mitigation strategies, and creating accountability for patient safety and scientific integrity across all assigned studiesDevelop and review critical study documents including clinical protocols, Medical Monitoring Plans, integrated reports, safety plans, and Informed Consent Forms in collaboration with sponsors and internal teamsBuild and maintain strong client relationships by actively soliciting feedback, addressing concerns, and driving continuous improvements in medical service delivery and client satisfactionSupport business development initiatives by participating in proposal development, attending bid pursuit meetings, and communicating Parexel's medical expertise and therapeutic area capabilities to prospective clientsDevelop and maintain advanced expertise in assigned therapeutic areas through continuous learning, training of colleagues, and contribution to internal knowledge-sharing initiatives including white papers and publicationsProvide medical input into pharmacovigilance workflows, participate in safety processing for serious adverse events, and support regulatory safety reporting activitiesMentor and coach junior team members on clinical trial processes, client collaboration, and professional development while fostering a culture of continuous improvementParticipate in departmental and team leadership initiatives to enhance operational efficiency, develop team capabilities, and support talent developmentMaintain flexibility to participate in on-call rotations for emergency medical contact and emergency unblinding requests as applicableUtilize key performance indicators and metrics to ensure high-quality, cost-effective delivery of medical servicesCandidate ProfileYou'll thrive in this role if you bring:Exceptional interpersonal and communication skills with the ability to influence sponsors, clients, and internal stakeholdersA client-focused approach with strong problem-solving and decision-making abilities at the enterprise levelExcellent medical and business writing skills with the ability to communicate complex clinical information clearlyStrong time management and organizational skills with the ability to manage multiple projects simultaneouslyA flexible, collaborative mindset with experience working effectively in matrix environmentsA patient-focused mindset and unwavering commitment to clinical trial integrity and patient safetyStrong attention to detail and ability to maintain accuracy in complex medical documentationWillingness to embrace continuous learning and stay current with evolving clinical research standardsRequired QualificationsMedical degree (MD, DO, or equivalent) from an accredited medical school with completion of at least basic clinical training (residency or internship)Minimum 10 years of experience in clinical medicine with a specialty in NephrologyStrong background in clinical aspects of drug development, including medical monitoring and study design/executionComprehensive knowledge of the drug development process, clinical trial regulations, and drug safetyClinical practice experience demonstrating medical expertiseKnowledge of ICH-GCP, regulatory requirements, and clinical trial processesExcellent verbal and written English communication skillsStrong problem-solving, risk assessment, and decision-making skillsPreferred QualificationsBoard certification in Pharmaceutical Medicine or related specialtyExperience as a Global Lead Physician or Regional Lead Physician in a CRO environmentDemonstrated experience in business development and proposal developmentExperience with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), or Electronic Data Capture (EDC) systemsUnderstanding of the CRO business model and clinical research operationsTrack record of mentoring and developing junior medical professionalsBenefits and CompensationHealth, Vision & Dental InsuranceTuition ReimbursementVacation/Holiday/Sick TimeFlexible Spending & Health Savings AccountsWork/Life Balance401(k) with Company matchPet InsuranceFor a complete list of benefits, please visit www.parexel.com/us-benefits.We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.Position Location: Remote – US or Canada
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