Senior Global Program Safety Team Lead - RLT (80-100%)Job ID: REQ-10023623
Oct 09, 2024
SummaryPrimary Location: Basel, Switzerland (80-100%)
Alternate Location(s): Barcelona, Spain
Working model: Both locations have a hybrid working model (12 days per month in the office)
About the RoleAre you ready to lead the charge in improving patients' lives and driving impactful results at Novartis? As the Senior Global Program Safety Team Lead - RLT (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. To this end, 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 requiredSpecialty Board Certification is desirableExperience in Radioligand and/or Nuclear Medicine is desirable.3-5 years of experience in OncologyMinimum 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 documentsStrong experience in leading cross-functional, multi-cultural teamsStrong experience with (safety or others) issue managementStrong experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publicationsStrong leadership skills including coaching, motivating, and directing, and fostering teamworkLanguages: Fluent English (both spoken and written) is essentialUnderstanding 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.Closing date for applications: 23 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!
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.
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