Medical Director – Oncology

🔥 14 hours ago

🇵🇱 Poland – 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 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

• 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

• Equal opportunity employment • Reasonable accommodations for candidates with disabilities during recruitment and selection upon request

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