Medical Director - Rheumatology

July 24

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Provide medical and safety monitoring for assigned projects • Provide medical expertise and leadership to support business development and pre-award activities • Medical Support / Medical Monitoring for projects and studies contracted to Parexel • Deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor and according to the assigned role • Participate actively in study planning with feasibility leaders, solution consultants • Participate in team project and investigator meetings • Provide training of study teams on TA indication and protocol • Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study • Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans, integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. • Deliver medical monitoring activities according to MMP during the study conduct • Answer to site/ study team questions relating to the study conduct or protocol • Review and sign off all data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans • Deliver medical leadership to the project in close coordination with the Project Leader • Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events • Support regulatory safety reporting activities • Ensure client needs and concerns are addressed to ensure customer satisfaction • Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction • Follow up sponsor satisfaction metrics pertaining to medical activities in assigned studies • Support Business Development, as agreed with Line Manager • Provide medical expertise/ leadership in Proposal Development Teams for client bid pursuit meetings • Provide medical expertise to client as contracted across multiple channels and interactions

🎯 Requirements

• Medically qualified in an acknowledged medical school with completion of applicable clinical training (residency, internship, fellowship) • Board certified/Board eligible in Rheumatology with extensive clinical experience • Expertise in Osteoarthritis, SLE, vasculitis and gout are preferred • Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience • Experience in clinical medicine (general or specialist qualifications) with a specialty Fellowship in a “therapeutic area” which is expected to be kept up-to-date • Experience leading, mentoring and managing individuals/ a team, preferred, but not essential • A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred • Good knowledge of the drug development process including drug safety, preferred • Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts • Excellent time management skills • Client-focused approach to work

🏖️ Benefits

• EEO Disclaimer • Equal opportunity employer