Medical Director – Oncology

🔥 17 hours ago

🇨🇿 Czechia – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 11%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• 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

• 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

• Equal opportunity commitment • Accommodations for candidates with disabilities upon request

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