Everest Clinical Research
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 ensures subject safety, data integrity, and protocol compliance, acting as the primary medical contact for investigative sites and sponsors while contributing to clinical and scientific discussions.
Key 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.
Required
- • Doctor of Medicine (MD) from an accredited institution.
- • Minimum of 15+ 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.
Preferred
- • 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.
Benefits & Perks
- • Medical, dental, and vision coverage
- • Life & AD&D insurance
- • Short- and long-term disability
- • Tuition reimbursement
- • Fitness reimbursement
- • Employee assistance program (EAP)
- • 401(k)/pension plan
- • Generous paid time off and sick leave
- • Opportunity to earn a performance based bonus
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 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)
We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k)/pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com
Estimated Salary Range: $250,000 - 325,000.
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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 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.
- 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.
- 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 15+ 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.
- Therapeutic area expertise in oncology, hematology, or related fields preferred.
- Experience contributing to protocol development and clinical study design preferred.
- 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.
- Experience working on global, multi-regional clinical trials preferred.
We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k)/pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com
Estimated Salary Range: $250,000 - 325,000.
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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