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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 lead cross-functional teams and manage complex clinical studies while ensuring patient safety and data integrity.
Highest-signal resume keywords
Medical MonitoringClinical Trial OversightPharmacovigilanceRegulatory ComplianceCross-Functional Team Leadership
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 DevelopmentMedical Data ReviewSafety OversightRisk ManagementProtocol DevelopmentStudy DesignEmergency Medical GuidancePatient ManagementStatistical Analysis ReviewAdverse Event Reporting
Soft Skills
LeadershipOrganizational SkillsCommunication SkillsInterpersonal SkillsTeamwork
Tools & Technologies
CTMSMedDRAWHODrugSOPs
Certifications & Qualifications
Doctor of Medicine (MD)Advanced Certification in Hematology or Oncology
Industry Keywords
Clinical TrialsFDA RegulationsEMA RegulationsICH-GCP GuidelinesPhase I-IV Studies
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 and first point of contact for clinical trial sites
- Answer site questions regarding 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 with cross-functional teams and sponsors
- Develop Medical Monitoring Plans and Safety Management Plans
- Review protocols and protocol training materials
- Train project teams on disease or therapeutic area, study design, and procedures
- Attend and participate in Investigator Meetings when applicable
- Support decisions on 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 answers in the centralized tracker/CTMS
- Review listings, laboratory reports, subject profiles, safety data, serious adverse events, medical history, and concomitant medications
- Assess patient risk and identify safety trends or signals
- Consult on out-of-range laboratory values for clinical and protocol significance
- Advise Pharmacovigilance/Drug Safety on SAE case assessment and reporting
- Review subject narratives, periodic and interim safety reports, and study documentation
- Assist with medical review of MedDRA and WHODrug coded terms
- 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
- Practical experience in medical research or clinical development
- At least 10–15 years of experience in clinical development, with a 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
- Advanced certification, specialization, or therapeutic-area expertise in hematology, oncology, or another relevant medical field highly preferred
- Strong leadership, organizational, and communication skills
- Ability to work collaboratively in cross-functional teams and interact effectively with internal and external stakeholders
- Expertise in medical data review, safety oversight, and risk management in clinical trials
- 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
- Experience working with global clinical trials and multi-regional study teams
- Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused
Benefits
Comp & perks- Equal opportunity and accommodations for candidates with disabilities upon request