Associate Clinical Development Medical Director

Job Title: Associate Clinical Development Medical Director

#LI-Hybrid

Primary Location: Barcelona, Spain

Other Locations: Dublin, Ireland; London, UK

Relocation Support: This role is based in Barcelona, Spain, Dublin Ireland or London, UK. Novartis is unable to offer relocation support: please only apply if accessible.

Make your impact by providing clinical and medical leadership for pivotal trials—aligning feasibility with real‑world practice, accelerating start‑up, and safeguarding patient safety and data quality across the country. You’ll partner with investigators, site teams, regulatory bodies, and internal functions to streamline recruitment and resolve trial challenges while offering clear scientific guidance that optimizes protocols and enhances patient engagement.

Job Description

• Provides Clinical Development and indication expertise specific to Country, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned time- lines:
• Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
• Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
• Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form (ICF) as needed and ensures appropriateness of patient suitable language.
• Provides scientific/clinical/medical expertise during interactions with Country external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
• Develops clinical/medical trial plans taking the broader ecosystem into account for assigned pro- grams/trials to ensure successful trial implementation, which includes:
• Provides robust indication, compound, and protocol training:
• Leverages innovation in clinical trial planning and decides on clinical/medical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials, and patient engagement.
• Gathers, informs, and acts on insights from clinical trial Investigators/site staff, Medical Experts, patients, and payers, with internal Stakeholders at the Country level with the goal to optimize clinical trial implementation.
• Supports planning, implementation, and follow-up of scientific/clinical/medical components of Regulatory Authority inspections and internal audits.
• Reviews and resolves Country trial-related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team.

Role Requirements

Education & Experience                  

• MD/DO or equivalent, with training in cardiology preferred.
• Knowledge and clinical training in siRNA desirable

Protocol Execution:

• Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial.
• Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
• Ability to assess the feasibility of implementing the protocol based on Country medical practice and sound understanding of the overall Clinical Development Plan.
• Demonstrates a high level of understanding of the protocol to train others, including site personnel.
• Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues.
• Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.
• Demonstrates current knowledge of relevant Country regulations and compliance requirements and communicates to Global teams as required.​Demonstrates knowledge of applicable SOPs, policies, procedures, and guidance documents.
• Expertise to represent the company as safety expert for clinical trials to external Regulatory and compliance bodies such as Regulatory Authorities, Health Boards, and REB/EC.

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