Global Program Safety Team Lead

Step into a career-defining opportunity where your leadership can transform patient outcomes on a global scale! As our Global Program Safety Team Lead in Neuroscience, you’ll be the driving force behind our Medical Safety organization, championing innovative safety strategies and steering our development programs toward breakthrough results.

In this pivotal role, your expertise as a safety clinician will empower you to anticipate and navigate complex safety challenges, influence high-stakes decisions, and inspire teams to achieve excellence. Your vision and strategic insight will shape the future of neuroscience safety at Novartis, making a lasting impact for patients worldwide.

Key Responsibilities:

• Manage an efficient and successful disease area within the Therapeutic Area (TA)/Development Unit (DU) Medical Safety organization, which provides robust medical and science-driven contribution to BenefitRisk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide
• Enhance scientific and clinical experience of Medical Safety physicians / scientists through continuous training and coaching.
• Prepares safety objectives and evaluates and manages performance of the Medical Safety associates within the TA/DU.
• Identifies talents and high potential associates and is able to defend and discuss in front of leadership team.
• Together with associates identifies carrier development opportunities and support associates in the carrier path
• Provide expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT) -Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management
• Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources.
• Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities and for responses to inquiries from regulatory authorities or health care professionals on safety issues
• Leading the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members
• Contribute to and often leading the development of departmental and functional/business unit goals and objectives
• Deputizing for Development Unit Head of Neuroscience as required

Essential Requirements:

• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable.
• 5 years clinical experience postdoctoral
• At least 7 years progressive experience in drug development in a major pharmaceutical company (of which 5 years in a global position), including 5 years in safety at a medical position
• Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information – to include NDA submission documents
• Strong experience in leading cross-functional, multicultural teams
• Strong experience with (safety or others) issue management
• Strong experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publication
• Strong leadership skills including coaching, motivating and directing, and fostering teamwork.
• Ability to develop and maintain effective working relationships with subordinates, superiors and peers

Beneficial skills and knowledge:

• Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
• Strong negotiation and conflict management skills
• Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs

Languages:

Fluent English (both spoken and written) is mandatory. Additional languages are an advantage.

Ready to make a difference? Apply now and help us reimagine medicine for millions of patients worldwide.

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? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.