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Independent consultant providing senior-level medical oversight, safety leadership, and clinical strategy for biotech and pharma companies, as well as specialized medical support for CROs.

About the Role

As an MD, PhD with over 20 years of global clinical development experience—including 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. Based in Switzerland and operating globally, I provide direct, senior-level accountability for clinical programs, ensuring continuity from protocol design through submission.

Responsibilities

• Real-time medical monitoring, eligibility reviews, and investigator support.
• Safety oversight, including signal detection, risk management, and medical review of SAEs/AEs.
• CRO oversight, managing and auditing medical activities to ensure high standards and quality.
• Authorship and review of critical clinical documents, including protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and regulatory briefing materials.
• Holistic patient review, assessing laboratory data, imaging results, adverse events, concomitant medications, and medical history in context.
• Preparation of safety reports (PBRER, DSUR, RMP), aggregate safety data analysis, benefit-risk assessments, and regulatory safety reporting.
• Support for regulatory interactions, including briefing packages, Q&A preparation, and strategy alignment for FDA, EMA, BfArM, and other authorities.
• DMC/DSMB support, KOL and Principal Investigator liaison, and oversight of vendors.

Therapeutic Expertise

• Oncology: Lung, head & neck, prostate, skin, and gynecological cancers; hematologic malignancies.
• Immunotherapy: Including personalized therapy approaches.
• Autoimmune Diseases: IgA nephropathy, Multiple Sclerosis (MS), Systemic Lupus Erythematosus (SLE).
• Rare diseases.

Qualifications

• MD and PhD in Immunology & Cancer Immunotherapy, University of Oslo.
• Over 20 years of clinical trial experience (Phase 1–3).
• Former Senior Medical Director and Global Safety Officer at GSK.
• Extensive experience in oncology, immunotherapy, and complex autoimmune programs.

Why Partner With Me?

• Direct Access: Work directly with an MD, PhD with 20+ years of experience.
• Continuity: Single point of accountability from protocol design through submission.
• Dual Perspective: Experience supporting both sponsors and CROs, driving efficiency and quality.
• Efficiency: Faster decision-making and high-quality deliverables without unnecessary overhead.

Collaboration Models

• Project-Based: Defined deliverables (e.g., protocol, IB, 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 full-time executive cost.

Publications

• Association of homogeneous inflamed gene signature with a better outcome in patients with metastatic melanoma treated with MAGE-A3 immunotherapeutic (2018).
• 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 (2017).
• Safety and Immunogenicity of the PRAME Cancer Immunotherapeutic in Patients with Resected Non-Small Cell Lung Cancer: A Phase I Dose Escalation Study (2016).

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