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Strategic Oversight for Biotech Sponsors Senior Oncology & Immunotherapy Medical Monitor MD, PhD and former Senior Medical Director at GSK with 20+ years of global clinical development experience. I provide independent Sponsor Medical Monitoring, Safety Oversight, and high-level Clinical Strategy for biotech and pharma companies, as well as specialized medical support for CROs. Book a Consultation MD, PhD and former Senior Medical Director at GSK with 20+ years of global clinical development experience. I provide independent Sponsor Medical Monitoring, Safety Oversight, and high-level Clinical Strategy for biotech and pharma companies, as well as specialized medical support for CROs. Sponsor Medical Monitoring & Safety Leadership How I Support Your Program Medical Monitoring Real-time medical oversight, eligibility reviews, and investigator support. Safety Oversight Signal detection support, risk management, and medical review of SAEs/AEs. CRO Oversight Managing and auditing CRO medical activities to ensure high standards and quality. Writing (as part of oversight) Personally authored/reviewed protocols, IBs, CSRs, and regulatory briefing materials. One Partner. Full Clinical Leadership. CRO medical oversight to improve quality and reduce rework 0+ Years clinical trial experience (Phase 1–3) 0yrs At GSK — Sr Medical Director, Global Safety Officer MD + PhD Immunology & Cancer Immunotherapy, Univ. of Oslo Swiss Switzerland-based Oncology, Immunotherapy & Beyond Therapeutic Expertise My core focus is Oncology and Immunotherapy (solid tumors and hematologic malignancies). I also bring deep expertise to complex autoimmune programs. Oncology: Lung, Head & Neck, Prostate, Skin, and Gynecological cancers.Immunotherapy: Including personalized therapy approaches.Hematologic malignancies.Autoimmune: IgA nephropathy, Multiple Sclerosis (MS), Systemic Lupus (SLE).Rare diseases Senior Expertise. Direct Accountability. No Handoffs. Why Partner With Me? Unlike a large CRO where your project may be assigned to rotating staff, I provide direct senior involvement and continuity. Bullets Direct Access: You work directly with an MD, PhD with 20+ years of experience.Continuity: I stay with your program from protocol design through to submission.Dual Perspective: I work with both Sponsors and CROs, giving an inside-out view of how to drive efficiency and quality.Efficiency: Faster decision-making and high-quality deliverables without unnecessary overhead. Medical oversight can become fragmented when responsibilities are split across multiple people. I founded Future Clinical Trials Consulting to provide direct, senior-level accountability — with clear medical decision-making and consistent rationale from early planning through execution and submission. Medical oversight can become fragmented when responsibilities are split across multiple people. I founded Future Clinical Trials Consulting to provide direct, senior-level accountability — with clear medical decision-making and consistent rationale from early planning through execution and submission. Senior Medical Monitor & Clinical Strategy Consultant Dr. Silvija Jarnjak MD, PhD With over 20 years of experience in global clinical development, I provide senior-level medical oversight and safety leadership for clinical programs. As an MD, PhD with a background from the University of Oslo and over nine years as a Senior Medical Director at GSK, I offer the strategic depth of Big Pharma combined with the agility of an independent expert. Expertise That Drives Milestones Oncology & Immunotherapy: Experience across solid tumors and hematologic malignancies. Autoimmune Diseases: Support for complex indications including SLE, MS, and IgA nephropathy. Sponsor–CRO Synergy: I support sponsors and also provide specialized medical support to CROs, enabling pragmatic oversight and efficient collaboration. How I De-risk Programs Ensuring Safety & Integrity: Sponsor medical monitoring and robust safety oversight. Optimizing Quality: Personally authoring/reviewing critical documents (protocols, IBs, CSRs) to support regulatory readiness. Strengthening Oversight: Improving CRO medical deliverables to prevent rework and delays. Based in Switzerland and operating globally, I am committed to bringing clinical trials to life through senior-level medical leadership. How I partner with CROs? I provide specialized medical support and senior-level consultancy for CROs requiring deep expertise in oncology, immunotherapy, or complex autoimmune indications (SLE, MS, IgA nephropathy). Why work with me? I combine Big Pharma medical leadership rigor with the agility of an independent consultant, offering continuity, direct accountability, and pragmatic decision-making to keep programs moving toward milestones. Bridging the Gap Between Science, Safety, and Strategy Partners & References Competence and expertise I present to you Dr. Jarnjak, distinguished Sr. Medical Advisor with whom we cooperated at HR One. Her professionalism reflects a harmonious blend of experience and a profound comprehension of the medical sector. HR One Group 1" style="display: none;"> We are proud to offer expertise Publications Library Association of homogeneous inflamed gene signature with a better outcome in patients with metastatic melanoma treated with MAGE-A3 immunotherapeutic 25.07.2018 Purpose: This study assessed clinical activity, safety and immunogenicity of MAGE-A3 immunotherapeutic in patients with MAGE-A3-positive metastatic… Safety and immunogenicity of MAGE-A3 cancer immunotherapeutic with dacarbazine in patients with MAGE-A3-positive metastatic cutaneous melanoma: an open phase I/II study with a first assessment of a predictive gene signature 14.11.2017 Background: We assessed safety, immunogenicity and clinical activity of recombinant MAGE-A3 antigen combined with AS15 immunostimulant (MAGE-A3… Safety and Immunogenicity of the PRAME Cancer Immunotherapeutic in Patients with Resected Non-Small Cell Lung Cancer: A Phase I Dose Escalation Study 16.08.2016 Introduction: Adjuvant platinum-based chemotherapy is standard treatment for surgically resected stage II to IIIA NSCLC, but the relapse rate is high.… FAQ A Fractional CMO provides senior clinical development leadership on a part-time or project basis. At Future Clinical Trials Consulting GmbH (FCTC), this includes medical monitoring, holistic patient review, safety oversight, regulatory strategy, and scientific document authoring — without the cost and commitment of a full-time executive. FCTC supports biotech companies developing oncology and immunotherapy products — from early Phase 1 programs through Phase 3 trials and regulatory interactions. Services are particularly suited for small to mid-sized biotech companies that require senior expertise but do not need a full-time CMO. Primary Expertise Includes OncologyImmunotherapyImmunology The scientific background includes MD and PhD training in immunology and cancer immunotherapy, with over 20 years of clinical trial leadership experience. Holistic Patient Review goes beyond CRF data entry. It involves expert clinical assessment of: Laboratory dataImaging resultsAdverse eventsConcomitant medicationsMedical history Each patient is evaluated in the context of their full medical profile to ensure high-quality safety oversight and sound clinical judgment. Yes. Ongoing Services Include Medical monitoring of trial patientsSAE/SUSAR assessment and causality evaluationDILI/hepatotoxicity monitoringDMC/DSMB supportCRO and vendor oversightKOL and Principal Investigator liaison Yes. Safety Services Include PBRER, DSUR, and RMP preparationAggregate safety data analysisBenefit–risk assessmentsRegulatory safety reporting (e.g., BfArM, FDA, EMA)Safety signal detection and escalation FCTC Provides Full-spectrum Medical And Regulatory Writing, Including Phase 1–3 protocols (including adaptive designs such as BOIN, BOP2, 3+3)Investigator’s Brochures (IB) and annual updatesClinical Study Reports (CSR)Clinical Development Plans (CDP)Briefing documents for Health AuthoritiesInformed Consent Forms (ICF/PIC) compliant with ICH-GCP and GDPR/DSGVOStatistical input coordination and figures/tables/listings Yes. FCTC supports preparation for meetings and submissions to authorities such as: Food and Drug Administration (FDA)European Medicines Agency (EMA)Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Services include briefing packages, Q&A preparation, and regulatory strategy alignment. FCTC Offers Flexible Collaboration Models Project-Based Defined deliverables such as a protocol, IB, or CDP with fixed scope and timeline. Retainer / Part-Time Ongoing medical monitoring, safety oversight, and CRO management. Embedded Fractional CMO Strategic and operational leadership as part of your team — without the full-time executive cost. Let's start a new study together Whether you're preparing for your first study or scaling a global program, our team is here to provide the expert guidance and partnership you need. Request More Information