Job ID
REQ-10061666
September 08, 2025
Switzerland
Summary
The incumbent will be responsible for all clinical and medical aspects associated with programs and trials within the country, providing strategic and tactical leadership. This role includes gathering, informing, and acting on scientific insights for clinical trial concept sheets, protocols, and other pertinent clinical documents to enhance the implementation of clinical trials.
The successful candidate will drive the identification and engagement of qualified investigators with the highest recruitment potential, address clinical recruitment challenges, and spearhead activities to resolve these issues. An emphasis will be placed on maintaining adherence to safety standards and ensuring the quality of clinical data in the country through comprehensive clinical and medical support for trial-related safety findings. Collaboration with line functions, such as clinical trial operations, Medical Affairs, and Patient Engagement, is essential to facilitate successful trial allocation, expedite trial startup, ensure timely recruitment, identify potential delays early, and develop mitigation plans where necessary.
About the Role
Job Description
- Providing clinical development and indication expertise specific to the country, and working with the clinical trial operations team to execute high-quality clinical trials within designated timelines.
- Validating study designs and making final decisions on the feasibility of implementing clinical trial protocols based on medical practice and competitive analysis in the country.
- Offering clinical and medical expertise to trial operations team members and clinical trial sites for IRB/Ethics Committee interactions.
- Deciding on site-specific scientific, clinical, and medical content for informed consent documentation as necessary, ensuring patient-friendly language.
- Providing scientific and clinical expertise during interactions with external experts, including regulatory authorities, medical experts, advisory boards, and patient advocacy groups.
- Developing clinical trial plans that account for broader ecosystems to ensure successful trial execution, which includes robust training on indication, compound, and protocol.
- Leveraging innovations in clinical trial planning and establishing recruitment strategies by conducting physician interviews, analyzing competitive trials, and engaging with patients.
- Collecting insights from clinical trial investigators, site staff, medical experts, patients, and payers, with internal stakeholders to optimize implementation.
- Supporting the planning, implementation, and follow-up of scientific and medical components for regulatory inspections and audits.
- Reviewing and resolving country trial-related scientific and clinical issues; initiating discussions with the Global Clinical Development team as necessary.
- Ensuring adherence to clinical safety standards and data quality, providing general scientific and medical support for safety-related issues.
- Supporting the Global Clinical Development team to clarify clinical protocol deviations through follow-up with trial sites.
- Identifying and conducting quality assessments of country datasets to support innovative study designs.
Role Requirements
Education & Experience
- MD/DO or equivalent, with a preference for training in cardiology.
- Knowledge and clinical training in siRNA is desirable.
Protocol Execution
- Demonstrating the ability to review and comprehend study protocols, addressing specific design questions.
- Applying a detailed understanding of the drug's medical context related to disease processes and standards of care.
- Assessing the feasibility of implementing protocols based on country medical practices and the overall Clinical Development Plan.
- Training others, including site personnel, based on a comprehensive understanding of the protocol.
- Evaluating compliance from investigators and study participants, alongside addressing patient safety concerns.
- Understanding regulatory requirements and internal policies for clinical trials, with current knowledge of country regulations.
- Representing the company as a safety expert before external regulatory and compliance bodies.
Why Novartis
At Novartis, our commitment goes beyond innovative science; it embodies the collaboration of smart, passionate individuals like you. Together, we can inspire each other and accomplish breakthroughs that profoundly change patients' lives. Ready to join us in creating a brighter future?
Apply online using the form below.
Only applications matching the job profile will be considered.
Accessibility and Accommodation
Novartis is dedicated to fostering an inclusive work environment. If you require reasonable accommodation due to a medical condition or disability during the recruitment process, please contact us at diversity.inclusion_ch@novartis.com, including your contact information and the nature of your request.
Company Details
Division: Development
Business Unit: Universal Hierarchy Node
Location: Switzerland (Basel City)
Company / Legal Entity: C028 (FCRS = CH028) Novartis Pharma AG
Alternative Locations: Dublin (NOCC), Ireland; London (The Westworks), United Kingdom
Functional Area: Research & Development
Job Type: Full time
Employment Type: Regular
Shift Work: No