Senior Global Program Safety Team Lead - CRM

Manage an efficient and successful disease area within the CRM 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 objective.

Take on a high impact opportunity where your leadership can help advance patient safety and improve outcomes across some of the world’s most significant cardiovascular, renal and metabolic diseases. As Senior Global Program Safety Team Lead in CRM, you will play a pivotal role within our Medical Safety organization—driving innovative safety strategies and guiding development programs that have the potential to make a meaningful difference for patients worldwide.

• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable

• Minimum 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

• Solid expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information – to include NDA submission documents

• Substantial experience in leading cross-functional, multicultural teams

• Strong experience with (safety or others) issue management

• Extensive 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