Senior Global Program Safety Team Lead
hace 2 días
About the Role
As the Senior Global Program Safety Team Lead - Radioligand Therapy, you will be at the forefront of our Medical Safety organization, ensuring robust safety risk management and making a positive impact on our development programs.
In this strategic leadership role, you will leverage your expertise as a seasoned safety clinician to predict safety risks and assess scientific information.
Your guidance will be instrumental in shaping strategic considerations and effective risk management for our teams.
Key Responsibilities:
- Manage 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.
- 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.
- Lead 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.
- Mentor junior CMO and Patient Safety personnel.
- Proactively engages in the development of competencies across the Medical Safety Function.
- Provide expert safety input to the clinical development program, in particular for heavy weight/high profile projects/products; is an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).
- Provide guidance and support to assigned Medical Safety team members.
- Responsible for safety issue management from formation of GPT through Life Cycle Management.
- Develop and be responsible for key internal Novartis safety documents, reviews these documents regularly and updates as required (e.g., when significant new information received).
- Own 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.
- 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.
- Constitutes and runs the Safety Management Team (SMT). Ensures that this team appropriately and timely reviews all medical safety data from various sources (e.g. pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process.
- Is responsible for documentation/tracking/record keeping of medical safety activities for the assigned compounds.
- Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet (core global labelling), including addressing safety issues optimally in all project/product labelling indications.
Role Requirements:
- Medical Degree required
- Specialty Board Certification is desirable
- Experience in Radioligand and/or Nuclear Medicine is desirable
- 3-5 years of experience in Oncology
- Minimum 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, 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
- Fluent English (both spoken and written) is essential
- Understanding in another major language (e.g. French, German, Spanish) is desirable
Skills:
- Clinical Research
- Clinical Trials
- Functional Teams
- Leadership
- Medical Strategy
- Process Safety Management
- Regulatory Compliance
- Safety Science
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