Clinical Research Medical Advisor - Immunology | Bm-039

Summary
The Clinical Research Medical Advisor - Immunology is a Global Clinical Development role with medical responsibility for the clinical trial process. It serves as a bridge between Study Site Operations (SSO) clinical trials and Medical Affairs, aligning technical, operations, and strategy. This position can be based remotely in Spain or alternatively hybrid onsite in Barcelona. We are ideally searching for a Medical Doctor (MD) in Immunology with Clinical Development experience.

About the Role

Key Responsibilities:
Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies within the respective therapeutic area. Support country strategy for Non-Interventional Studies/Investigator Initiated Trial activities.
Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents for frequently asked questions.
Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for stakeholder engagement and events are tailored to local needs and reviewed/approved per local guidelines.
Provide medical insights to cross functional groups, including Pharmacovigilance, Regulatory affairs, Market Access, QA, Commercial teams, Brand team, and others.
Responsible for risk identification and assessment, mitigation planning, and monitoring of appropriate internal controls within the area of responsibilities.
Report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.

Essential Requirements:
A MD (Immunology ideally) with experience as a Medical Advisor on clinical trials.
Experience working on Global Clinical Trials including Clinical Trial Design, Data & Reporting.
Knowledge of both SSO operational clinical trials and medical affairs.
Operations Management and Execution Project Management collaborating across boundaries.
Strong people and strategic planning skills to pull several different functions together on projects.
Strong communication and negotiation skills, plus the ability to speak, read, and write in English (essential).
A background as a Medical Science Liaison, Medical Affairs Specialist, or Study Lead/coordinator from a CRO as a Medical Advisor on a clinical trial would be considered.

Desirable Requirements:
Previous clinical experience with patients.

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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