Senior Medical Director

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Senior Medical Director.

The Senior Medical Director provides hands-on medical monitoring and clinical expertise to support the design, conduct, and interpretation of clinical trials. This role is responsible for ensuring subject safety, data integrity, and protocol compliance in accordance with ICH-GCP and applicable regulatory requirements.

Acting as the primary Medical Monitor for assigned studies, the Senior Medical Director serves as a key medical point of contact for investigative sites and sponsors, providing real-time medical guidance, reviewing safety data, and contributing to clinical and scientific discussions to support high-quality study execution.

Key Accountabilities:

Study-Level Medical Monitoring (Primary Responsibility)

• Serve as the primary Medical Monitor for assigned clinical trials
• Act as the first point of contact for investigative sites for medical questions related to eligibility, enrollment, and patient management
• Provide timely medical guidance on protocol-related questions, including inclusion/exclusion criteria and subject eligibility
• Be available to address medical questions and issues arising during study conduct, including urgent safety matters

Safety Review & Signal Detection

• Review and interpret safety data including serious adverse events (SAEs), adverse events (AEs), laboratory data, medical history, and concomitant medications
• Assess patient risk and identify potential safety trends or signals at the study level
• Provide medical input to Pharmacovigilance/Drug Safety teams for SAE assessment and reporting
• Review subject narratives, safety listings, and periodic or interim safety reports

Protocol & Scientific Contribution

• Provide medical input into protocol development, protocol amendments, and study-related documents
• Contribute to development of Medical Monitoring Plans and Safety Management Plans
• Participate in protocol training, study team training, and Investigator Meetings
• Support interpretation of study data and contribute to Clinical Study Reports (CSRs) and related documents

Cross-Functional & Sponsor Collaboration

• Collaborate with Clinical Operations, Data Management, Biostatistics, and Pharmacovigilance to support study execution and data quality
• Serve as a key medical contact for sponsors for assigned studies
• Respond to medical queries from investigators, Ethics Committees, and Data Monitoring Committees
• Participate in study team meetings, safety review meetings, and sponsor discussions

 Data Review & Documentation

• Perform ongoing review of listings, laboratory reports, and subject-level data as outlined in the Medical Monitoring Plan
• Ensure all protocol-related medical inquiries and responses are appropriately documented in CTMS or applicable systems
• Assist in review of Statistical Analysis Plans (SAPs), tables, listings, and figures (TLFs), and Clinical Study Reports (CSRs), as needed

Quality & Compliance

• Ensure medical monitoring activities are conducted in compliance with ICH-GCP, regulatory requirements, and company SOPs
• Provide medical support for audits and inspections as need