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Medical Director – Oncology
Everest Clinical Research. Work with business development and internal stakeholders to appraise protocols, propose study designs, and develop endpoints .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial oversight, medical monitoring, and regulatory compliance, with a strong foundation in clinical medicine and extensive experience in managing Phase I–IV clinical trials. Proficient in medical data review, safety management, and collaboration with cross-functional teams and stakeholders.
Highest-signal resume keywords
Doctor Of Medicine (MD)Clinical Trial OversightMedical MonitoringRegulatory Compliance (FDA, EMA, ICH-GCP)Pharmacovigilance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical Data ReviewSafety OversightRisk ManagementStudy DesignProtocol DevelopmentEmergency Medical GuidanceAdverse Event ManagementMedDRA CodingStatistical Analysis ReviewClinical Study Reporting
Soft Skills
LeadershipOrganizational SkillsCommunication SkillsInterpersonal SkillsTeamwork
Tools & Technologies
Centralized TrackerClinical Trial Management System (CTMS)
Certifications & Qualifications
Advanced Certification in HematologyAdvanced Certification in Oncology
Industry Keywords
Clinical DevelopmentContract Research OrganizationGlobal Clinical TrialsMulti-Regional Study TeamsSafety Management Plans
About the role
Key responsibilities & impact- Work with business development and internal stakeholders to appraise protocols, propose study designs, and develop endpoints
- Serve as primary medical monitor and first point of contact for clinical trial sites
- Answer site questions about eligibility and enrollment and perform safety and patient management
- Advise on medical questions and issues arising during clinical trials
- Define, plan, and provide medical monitoring for assigned trials with cross-functional teams and sponsors
- Develop and review Medical Monitoring Plans, Safety Management Plans, protocols, and training materials
- Train project teams on disease areas, study design, and procedures
- Attend and participate in Investigator Meetings when applicable
- Support decisions about inclusion/exclusion deviations and protocol-related questions
- Respond to medical queries from Investigators, Ethics Committees, and Data Monitoring Committees
- Provide emergency medical guidance outside normal business hours by telephone and email
- Document protocol inquiries and responses in the centralized tracker/CTMS
- Review listings, laboratory reports, subject profiles, safety data, serious adverse events, medical history, and concomitant medications
- Identify safety concerns and adverse events and develop and execute appropriate responses
- Advise study teams on out-of-range laboratory values and clinical or protocol significance
- Advise Pharmacovigilance/Drug Safety on SAE case assessment and reporting
- Review subject narratives, periodic and interim safety reports, and other study documentation
- Assist with MedDRA and WHODrug coding reviews
- Review Statistical Analysis Plans, tables, figures, listings, and Clinical Study Reports as needed
- Ensure compliance with company SOPs and clinical trial safety medical monitoring practices
Requirements
What you’ll need- Doctor of Medicine (MD) from an accredited institution
- Strong foundation in clinical medicine, with practical experience in medical research or clinical development
- At least 10–15 years of experience in clinical development, medical monitoring, clinical trial oversight, and pharmacovigilance
- Proven experience managing Phase I–IV clinical trials in a Contract Research Organization or pharmaceutical company environment
- In-depth knowledge of FDA, EMA, and ICH-GCP regulatory requirements
- Expertise in medical data review, safety oversight, and risk management in clinical trials
- Experience with global clinical trials and multi-regional study teams
- Advanced certification, specialization, or therapeutic-area expertise in hematology, oncology, or another relevant medical field highly preferred
- Strong leadership, organizational, communication, interpersonal, and teamwork skills
- Ability to work collaboratively with cross-functional teams and internal and external stakeholders
- High attention to detail and ability to make informed decisions based on clinical data
- Ability to maintain confidentiality and handle sensitive medical and client data responsibly
- Excellent customer- and quality-focused approach
Benefits
Comp & perks- Equal opportunity and accommodations for candidates with disabilities upon request
- Remote work arrangement