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Medical Director – Oncology
Everest Clinical Research. Work closely with business development and internal stakeholders to critically 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 medical monitoring, clinical trial oversight, and pharmacovigilance, with a strong foundation in clinical medicine and regulatory compliance. Proven ability to manage complex clinical trials and collaborate effectively with cross-functional teams.
Highest-signal resume keywords
Medical MonitoringClinical Trial OversightPharmacovigilanceRegulatory ComplianceClinical Data Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical DevelopmentSafety MonitoringRisk ManagementProtocol ReviewMedical ExpertiseStudy DesignAdverse Event AssessmentData MonitoringStatistical AnalysisMedical Guidance
Soft Skills
LeadershipCommunicationInterpersonal SkillsOrganizational SkillsTeamwork
Tools & Technologies
CTMSMedDRAWHODrugClinical Study ReportsSafety Management Plans
Certifications & Qualifications
Doctor of Medicine (MD)Advanced Certification in HematologyAdvanced Certification in Oncology
Industry Keywords
FDAEMAICH-GCPPhase I–IV StudiesContract Research OrganizationClinical TrialsGlobal Clinical TrialsMulti-Regional Study Teams
About the role
Key responsibilities & impact- Work closely with business development and internal stakeholders to critically appraise protocols, propose study designs, and develop endpoints
- Serve as primary medical monitor for assigned studies and first point of contact with study sites
- Answer site questions regarding eligibility and enrollment
- Perform safety monitoring and patient management
- Advise on medical questions and issues arising during clinical trials
- Work cross-functionally with sponsors to define, plan, and provide medical monitoring
- Develop and provide medical expertise for Medical Monitoring Plans and Safety Management Plans
- Review protocols and protocol training materials
- Train project teams on disease or therapeutic areas, study design, and procedures
- Attend and participate in Investigator Meetings when applicable
- Consult on inclusion/exclusion criteria deviations, subject eligibility, and protocol-related questions
- Respond to medical queries from Investigators, Ethics Committees, and Data Monitoring Committees
- Provide emergency medical guidance by telephone and email outside normal business hours
- Document protocol inquiries and answers in the centralized tracker/CTMS
- Review listings, laboratory reports, subject profiles, safety data, serious adverse events, medical histories, and concomitant medications
- Identify safety concerns, adverse events, and safety trends or signals, and develop appropriate responses
- Consult on out-of-range laboratory values for clinical and protocol significance
- Advise the Pharmacovigilance/Drug Safety team on SAE assessment and reporting
- Review subject narratives, periodic and interim safety reports, and study documentation
- Assist with medical review of MedDRA-coded adverse events and medical histories and WHODrug-coded concomitant medications or therapies
- Review Statistical Analysis Plans, tables, figures, listings, and Clinical Study Reports as needed
- Ensure compliance with company Standard Operating Procedures and working practices for clinical trial safety medical monitoring
Requirements
What you’ll need- Doctor of Medicine (MD) from an accredited institution
- Strong foundation in clinical medicine
- Practical experience in medical research or clinical development
- At least 10–15 years of experience in clinical development
- Strong background in medical monitoring, clinical trial oversight, and pharmacovigilance
- Proven experience managing clinical trials in a Contract Research Organization or pharmaceutical company environment
- Expertise in Phase I–IV studies
- In-depth knowledge of regulatory requirements, including FDA and EMA, and ICH-GCP guidelines
- Expertise in medical data review, safety oversight, and risk management in clinical trials
- Experience working with global clinical trials and multi-regional study teams
- Ability to work collaboratively in cross-functional teams and interact effectively with internal and external stakeholders
- Strong leadership, organizational, communication, interpersonal, and teamwork skills
- 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
- Customer- and quality-focused
- Advanced certification, specialization, or therapeutic-area expertise in hematology, oncology, or another relevant medical field highly preferred
- Additional certifications or training in specific therapeutic areas may be an advantage
Benefits
Comp & perks- Equal opportunity employment
- Reasonable accommodations for candidates with disabilities during recruitment and selection upon request