Summary

Novartis BioMedical Research (BR) is the innovation engine of Novartis. We collaborate across scientific and organization boundaries, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs from patients. Within BR, Translational Medicine (TM) is the clinical research arm and includes over 900 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application.

The Clinical Sciences Director is the clinical leader for indication and/or program-level activities leading to clinical Proof of Concept or NDA registration, achieving BR/Translational Medicine (TM), Global Drug Development (GDD)/Global Project Team (GPT) and/or ECN objectives.

• Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program and/or programs.
• Ensure effective cross-functional communications to align with global strategy -Leads development of clinical sections of trial and program level regulatory documents -Drives execution of the section of the clinical program in partnership with global line functions.
• Supports the clinical research leaders by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas -Acts as the medical expert, engages interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders -Contributes to medical/scientific training of relevant Novartis stakeholders.
• May serve as speaker for franchise medical/scientific training -May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) -Develops high potential talents for succession positions to ensure business continuity.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

• Approximately 10+ years in clinical trials with significant early phase drug development experience.
• Expert knowledge of Good Clinical Practice. Proven experience across multiple clinical indications or therapeutic areas.
• Track record of successfully managing multiple complex global Phase I and IIa clinical trials concurrently, supported by experience of Phase IIb/III clinical trials. Superior leadership and problem-solving skills.
• Excellent operational project and program management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
• Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects.
• Strategic thinking: create major innovations, ability to network with and influence opinion leaders, clear and logical presentation of complex strategic issues.
• Clear written and verbal expression of ideas, an active/proactive communicator. Excellent interpersonal skills, with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships.
• High level of customer orientation awareness and focus. Excels working independently and in a team environment, being flexible and adapting in a changing environment.

• English.