Global Program Safety Team Lead - Neuroscience
Hybrid · London, England, United Kingdom or Basel, Basel-City, Switzerland
Job Summary
Lead the Global Program Safety Team in Neuroscience for Novartis, driving safety strategy and medical safety contribution across the development lifecycle. Manage an efficient disease-area Medical Safety organization, coach safety physicians/scientists, set safety objectives, evaluate performance, identify talents, and support career development. Provide expert safety input to clinical development programs as an active Global Program Team member, oversee safety issue management from GPT formation through Life Cycle Management, drive signal detection, monitoring, interpretation, and regulatory responses, and lead preparation of safety strategies for health authority interactions. Lead cross-functional, multicultural teams and collaborate on safety documentation such as RMPs and PSURs, with a focus on delivering safe medicines to patients worldwide. Fluency in English; additional languages advantageous. Hybrid work arrangement with 12 on-site days per month in Basel, Switzerland, and an alternative based in London, UK.
Required Qualifications
- 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 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
- Languages: Fluent English - both spoken and written
- Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) (Beneficial)
- Strong negotiation and conflict management skills
- Strong experience with medical writing and delivering high quality documents such as RMPs, PSURs
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