Global Therapeutic Area Lead, Nephrology

Parexel•Quebec, ON

1d•Remote

About The Position

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. Parexel 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®. We 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.

Requirements

Medical 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 Nephrology
Strong background in clinical aspects of drug development, including 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

Nice To Haves

Board certification in Pharmaceutical Medicine or related specialty
Experience as a Global Lead Physician or Regional Lead Physician in a CRO environment
Demonstrated experience in business development and proposal development
Experience with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), or Electronic Data Capture (EDC) systems
Understanding of the CRO business model and clinical research operations
Track record of mentoring and developing junior medical professionals

Responsibilities

Independently 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 Physician
Lead medical monitoring activities including protocol review, Medical Monitoring Plan development, and sign-off on data listings, protocol deviations, and datasets for medical accuracy and consistency
Provide strategic medical leadership by identifying risks, proposing mitigation strategies, and creating accountability for patient safety and scientific integrity across all assigned studies
Develop 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 teams
Build and maintain strong client relationships by actively soliciting feedback, addressing concerns, and driving continuous improvements in medical service delivery and client satisfaction
Support business development initiatives by participating in proposal development, attending bid pursuit meetings, and communicating Parexel's medical expertise and therapeutic area capabilities to prospective clients
Develop 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 publications
Provide medical input into pharmacovigilance workflows, participate in safety processing for serious adverse events, and support regulatory safety reporting activities
Mentor and coach junior team members on clinical trial processes, client collaboration, and professional development while fostering a culture of continuous improvement
Participate in departmental and team leadership initiatives to enhance operational efficiency, develop team capabilities, and support talent development
Maintain flexibility to participate in on-call rotations for emergency medical contact and emergency unblinding requests as applicable
Utilize key performance indicators and metrics to ensure high-quality, cost-effective delivery of medical services