Clinical Research Medical Advisor

Key Responsibilities:

• Provides Clinical Development and indication expertise specific to Country/Cluster, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned timelines.
• 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. Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
• 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/Cluster 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 programs/trials to ensure successful trial implementation, which includes: pro-actively identifying early on clinical challenges to recruitment or clinical data quality and drives development of clinical/medical mitigation plans, building disease area expertise, especially for new/rare indications.
• 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.
• As the scientific/clinical/medical expert, supports and partners with internal stakeholders and internal decision boards as needed. Gathers, informs, and acts on insights from clinical trial Investigators/site staff, Medical Experts, patients, and payers, with internal Stakeholders at the Country/Cluster 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.
• Accountable for adherence to safety standards, clinical data quality for the Country/Cluster and provides general scientific/clinical/medical support for safety issues. Supports the Global Clinical Development team as needed to address/clarify clinical/medical Protocol Deviations through follow-up with clinical trial sites.
• May support innovative study designs by identifying and conducting quality assessments of Country datasets (e.g., Registries, Electronic Health Records, Payer data, Real World Data, etc.). Drives all clinical/medical activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and Country regulations.
• Provides scientific/clinical/medical input to the overall Product strategy at the Country level with an optimized cross-functional Country team. May represent Clinical Development at internal and external meetings. Provides a superior customer experience for Investigators/site study teams, significantly impacting the external visibility and reputation of Novartis.

Essential Requirements:

• Education: Scientific degree.
• Min 2-3 years of experience from medical affairs/clinical environment.
• Proficient Danish and English, both written and spoken.
• Ability to manage a study from the scientific/medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.
• Demonstrated problem-solving skills and comfort with complexity, agility to move quickly across different therapeutic areas and indications.
• Sound understanding of the overall clinical development process, and ICH/GCP principles.
• Project management experience, stakeholder engagement.
• Good communication and negotiation skills, ability to prepare and deliver high quality presentations.

Desirable Requirements:

• Education: PHD or MD degree.

About Novartis Denmark:

Novartis is a leading pharmaceutical company renowned for its innovation. In Denmark, we pioneered the introduction of advanced cell and gene therapies. Our commitment to research and development spans a wide range of therapeutic areas, including oncology, chronic conditions, and rare diseases. We take pride in being a proactive partner, contributing to the advancement of healthcare solutions.

As a global pharmaceutical leader headquartered in Switzerland, Novartis is among the largest pharmaceutical companies in Denmark. Our mission is to lead in delivering innovative medicines to patients across the country. We are dedicated to fostering a dynamic work environment that promotes personal development and professional growth.

What we offer:

• Competitive salary, annual bonus and pension scheme
• Health insurance
• Flexible working arrangements
• Inclusive work environment, many social activities and a highly active social committee

Commitment To Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.