Medical Director

Everest Clinical Research

15h

About The Position

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 Medical Director. The 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 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.

Requirements

Doctor of Medicine (MD) from an accredited institution. A strong foundation in clinical medicine, combined with practical experience in medical research or clinical development, is essential. Additional certifications or training in specific therapeutic areas (e.g., hematology, oncology) may be an advantage, but the primary qualification must be an MD or equivalent medical degree.
Minimum of 10+ years of experience in clinical development, including significant experience in medical monitoring and clinical trial oversight
Prior experience serving as a Medical Monitor on Phase I–IV clinical trials in a pharmaceutical, biotechnology, or CRO setting
Strong knowledge of clinical trial methodology, safety assessment, and medical data review
Understanding of ICH-GCP, FDA, EMA, and global regulatory requirements
Demonstrated ability to interact effectively with investigative sites, sponsors, and cross-functional teams
Strong communication, clinical judgment, and decision-making skills
High level of attention to detail and ability to manage multiple priorities

Nice To Haves

Therapeutic area expertise in oncology, hematology, or related fields preferred
Experience contributing to protocol development and clinical study design preferred
Experience working on global, multi-regional clinical trials preferred

Responsibilities

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
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
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
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
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
Ensure medical monitoring activities are conducted in compliance with ICH-GCP, regulatory requirements, and company SOPs
Provide medical support for audits and inspections as needed
Maintain high standards of data quality, consistency, and patient safety throughout the study