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Medical Director – Oncology
Everest Clinical Research. Work 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 clinical trial oversight, medical monitoring, and pharmacovigilance, with a strong foundation in clinical medicine and regulatory compliance. Capable of providing medical input and guidance throughout all phases of clinical trials while ensuring safety and adherence to protocols.
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 DevelopmentMedical Data ReviewSafety OversightRisk ManagementProtocol ReviewStudy DesignEndpoint DevelopmentAdverse Event AssessmentStatistical Analysis ReviewEmergency Medical Guidance
Soft Skills
LeadershipCommunicationInterpersonal SkillsTeamworkAttention to Detail
Tools & Technologies
CTMSMedDRAWHODrugStatistical Analysis Plans
Certifications & Qualifications
Doctor of Medicine (MD)Advanced Certification in HematologyAdvanced Certification in Oncology
Industry Keywords
FDA RegulationsEMA GuidelinesICH-GCPPhase I-IV StudiesContract Research Organization
About the role
Key responsibilities & impact- Work 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 about eligibility and enrollment; 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 provide medical input to 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 concerning 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, medical histories, concomitant medications, and patient-risk trends
- Provide medical oversight to identify safety concerns and adverse events and develop appropriate responses
- 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-coded adverse-event and medical-history terms and WHODrug-coded concomitant medications/therapies
- Review Statistical Analysis Plans, tables, figures, listings, and Clinical Study Reports as needed
- Ensure compliance with company Standard Operating Procedures and clinical-trial safety medical-monitoring practices
Requirements
What you’ll need- Doctor of Medicine (MD) from an accredited institution
- A strong foundation in clinical medicine, with 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
- 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 maintain confidentiality and responsibly handle sensitive medical and client data
- Strong leadership, organizational, communication, interpersonal, teamwork, and collaboration skills
- High attention to detail and ability to make informed decisions based on clinical data
- 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 advantageous
Benefits
Comp & perks- Equal opportunity commitment
- Accommodations for candidates with disabilities upon request