Director, Translational Patient Safety

Summary

Join our team as Director of Safety Science and Translational Patient Safety, you will lead the charge in evaluating and understanding emerging safety signals and risks across all therapeutic areas. Your expertise will be crucial in integrating mechanistic safety insights into the entire drug lifecycle, from research to commercialization. This role offers the opportunity to collaborate with top-tier professionals and ensure the safety of groundbreaking drugs, making a significant impact on patient safety and pharmacovigilance.

About the Role

Key Accountabilities

• Co-chair and conduct regular and ad hoc meetings of the investigative Liver Expert Team (iLET)
• Support the Chair of the Medical Safety Review Board (MSRB) in preparing scheduled and ad hoc meetings of MSRB and the Global Labeling Committee (GLC). This includes preparatory meetings with teams presenting at MSRB, ensuring that the scientific content meets the required standards for discussion at MSRB
• Ensure that all deliverables are performed timely, accurately and completely.
• Detailed understanding of Safety Signal Management and all associated processes. Coordinate the preparation of audits and inspections in close collaboration with associated teams in Medical Safety, notably Medical Safety Operations and Signal Detection
• Deputize for the Global Head of Safety Signal Management and Mechanistic Safety in meetings of the Program Management Committee (PMC) and the Integrative Safety Assessment Board (ISAB)
• Active participation in expert safety panels that fall under the leadership of Mechanistic Safety
• Contribute to overall training of Patient Safety and Development Physicians
• Initiate, lead and maintain productive cross-functional mechanistic safety collaborations internally with colleagues
• Sustain Novartis' leading role in external collaborations in the field of Drug-Induced Liver Injury, notably coordination and participation in key strategic cross-industry consortia. Maintain close collaboration with key opinion leaders in the field and with the FDA leaders in the DILI field. Actively participate and represent Novartis interests in the FDA DILI Conference.

Role Requirements:

Education:

• Scientific MD or Medical PhD
• Fluent English (both spoken and written) is essential
• Fluent German is an advantage

Work Experience & Skills:

• 3-5 years postdoctoral or clinical experience.
• Minimum 5 years in drug development related experience in either academia or a major pharmaceutical company
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information
• Experience in leading cross-functional, multi-cultural teams
• Experience with (safety or others) issue management
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
• Management experience (direct reports or leading complex teams)

Closing date for applications: 07 October 2024

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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

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Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Development

Business Unit
Innovative Medicines

Location
Switzerland

Site
Basel (City)

Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG

Alternative Location 1
London (The Westworks), United Kingdom

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regulär

Shift Work
No