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 for 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.
About the Role
Major accountabilities:
- Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program and/or programs.
- Ensures 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, engaging in 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).
Minimum Requirements:
Advanced degree (or equivalent education) in life sciences/healthcare required. PhD/PharmD strongly preferred.
Experience/Professional Requirement:
- 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 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.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
Functional Area: Research & Development
Job Type: Full time
Employment Type: Regular
Shift Work: No