Senior Global Program Safety Team Lead

Major accountabilities:

• Manages an efficient and successful disease area within the TA/DU Medical Safety organization, which provides robust medical and science-driven contribution to Benefit-Risk evaluation throughout product lifecycle to enable Novartis to provide impactful medicines to patients worldwide.
• Leads the day-to-day safety activities and provides guidance to assigned Medical Safety team members and mentee(s), as well as to the direct reports. Prepares objectives and evaluates related performance for the assigned team members.
• Provides expert safety input to the clinical development program, in particular for priority compounds; is an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).
• Responsible for the review of PSURs together with QPPV office. Takes responsibility for MSRB presentations for his products/teams.
• Owns the safety strategy and documents it appropriately (e.g. dSPP, SSPT); leads the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products.
• 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.
• Initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications.
• Responses to inquiries from regulatory authorities or health care professionals on safety issues. Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members. Prepares safety data for health authority review boards (together with the clinical and biostatistical functions). Attends Health Authority Meetings in person, as required.
• Prepares and presents safety issues to internal Novartis Boards and other meetings as required. Provides input to all relevant internal meetings with senior management (e.g., DevLT, TA LT, Medical Safety LT etc.) and other meetings as deemed necessary (e.g., GPT, SMT; GCT etc.)
• Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues within PS&PV and those from other functions, e.g. Clinical Development and Medical Affairs, Regulatory Affairs, Medical Information, Biostatistics, Clinical Pharmacology, QA, BD&L and BR, as well as externally with expert panels and other scientific contacts.

Education:

Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable.
Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent).

Work Experience:

• 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. 5+ years clinical experience postdoctoral
• 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, multi- cultural 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 publications
• Strong leadership skills including coaching, motivating, and directing, and fostering teamwork
• Ability to develop and maintain effective working relationships with subordinates, superiors and peers
• Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs