Sr. Global Program Safety Team Lead (Immunology)

Band

Level 6

 

Job Description Summary

The Sr Global Program Safety Team Lead (Immunology) serves as strategic leader of the Medical Safety organization to improve patients’ lives and impact on overall Novartis results through robust safety risk management. This role requires an experienced and knowledgeable safety clinician responsible to predict safety risks and assess scientific information to guide the assigned
teams on strategic considerations, effective risk management and overall positive impact in development programs.
Ensures optimal patient safety for assigned compounds, is responsible for the integration, analysis, and interpretation of internal and external safety information from all sources through lifecycle management.
This is a management position requiring excellent collaboration skills and matrix leadership, who will work closely with the Head Patient Safety managing complex safety issues across several indications.

 

Job Description

Major accountabilities:

• Manages 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 
• Enhances 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
• Provides 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
• Is 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
• Is responsible for 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 -Contributes to and often leads the development of departmental and functional/business unit goals and objectives
• Distribution of marketing samples (where applicable)

Key performance indicators:

• Timeliness and quality of safety analyses, interpretations, and presentations and communication in all the assigned programs
• Strategic input and guidance in the assigned programs
• Compliance with internal SOPs/WPs and external regulations & procedures

Essential Requirements:

• 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)
• 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

Desirable Experience

• Strong negotiation and conflict management skills
• Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs