Medical Director – Oncology

🔥 17 hours ago

🇭🇷 Croatia – 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 study 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 clinical trials 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 areas, study design, and procedures • Attend and participate in Investigator Meetings when applicable • Consult on inclusion/exclusion criteria 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 • Identify safety concerns, adverse events, risks, trends, and safety signals and develop appropriate responses • Consult on out-of-range laboratory values for clinical and protocol significance • Advise Pharmacovigilance/Drug Safety on SAE assessment and reporting • Review subject narratives, periodic and interim safety reports, and other 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 Standard Operating Procedures and clinical trial safety medical monitoring practices

🎯 Requirements

• 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 • Advanced certification, specialization, or therapeutic area expertise in hematology, oncology, or another relevant medical field is highly preferred • Proven experience managing clinical trials in a Contract Research Organization or pharmaceutical company environment • Expertise in Phase I-IV studies • In-depth knowledge of FDA, EMA, and ICH-GCP guidelines • 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 • 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-focused, and quality-focused

🏖️ Benefits

• Remote work arrangement • Equal opportunity employment • Recruitment and selection accommodations for candidates with disabilities upon request

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