Senior Medical Director

🔥 13 hours ago

🌐 Spain, Germany, +4 more countries – Remote

🇪🇸 Spain – Remote 🇩🇪 Germany – Remote 🇸🇪 Sweden – Remote 🇬🇧 United Kingdom – Remote 🇵🇱 Poland – Remote 🇵🇹 Portugal – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Act as medical monitor for assigned oncology studies • Provide protocol-related medical review, eligibility and dose-modification guidance, and medical input to data review meetings • Provide medical oversight and act as the escalation point for oncology studies across the assigned portfolio • Advise on study design and measurements in clinical trials • Review safety sections of study protocols and Investigator’s Brochures • Review safety listings, adverse events, laboratory listings, vital signs and ECG data • Review clinical trial reports from a safety perspective • Assess adverse events and serious adverse events • Conduct senior medical review of individual safety cases, cumulative case listings, PSURs, PBRERs, DSURs and Risk Management Plans • Provide medical input to regulatory documents • Conduct literature reviews and signal detection activities • Contribute to departmental SOPs and tools • Educate and supervise new Medical Advisors and Medical Directors • Serve as a senior scientific voice in targeted oncology and hematology indications • Represent the company at scientific and industry meetings, presentations, panels and advisory boards • Contribute to publications, congress abstracts, white papers and articles • Provide medical review of oncology communication materials • Build and maintain networks of KOLs and investigators • Monitor competitive landscapes, emerging standards of care and sponsor development pipeline trends • Partner with Business Development on bid strategy, proposals, bid defense meetings and sponsor discussions • Provide medical and scientific rationale for study design, feasibility and delivery strategy • Develop sponsor relationships and contribute to oncology therapeutic-area strategy and service offerings

🎯 Requirements

• Medical degree (MD) • Specialist medical training • At least 10 years of post-qualification medical experience • At least 7 years of oncology/haematology clinical development experience • Substantial experience in a Medical Director role or equivalent in a CRO, biotechnology, or pharmaceutical organization • Hands-on experience as medical monitor in oncology clinical trials, including review of emerging safety data and medically based decision-making during study conduct • Experience as a member of safety data review boards in clinical trials, or equivalent experience • Understanding of Good Clinical Practice regulations, International Council for Harmonisation (ICH) guidelines, Pharmacovigilance legislation and internal Standard Operating Procedures • Excellent written and verbal communication skills • Ability to work in a fast-paced environment with changing priorities • Willingness to travel internationally for sponsor meetings and scientific events • Experience of sponsor-facing scientific work in a CRO, pharmaceutical or biotechnology environment (desirable) • Ability to translate scientific depth into a clear and credible message in sponsor-facing settings (desirable) • Established external scientific profile in oncology, such as publications, congress presentations, advisory board participation or an active Key Opinion Leader network (desirable)

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Personal and professional growth opportunities • Collaborative and innovative work environment • Opportunity to make a difference in patients’ lives • International travel opportunities for sponsor meetings and scientific events