Sr. Global Program Safety Team Lead (Immunology) – Novartis, East Hanover, NJ
Job Summary
Novartis is hiring a Senior Global Program Safety Team Lead (GPSTL) in Immunology, based on-site in East Hanover, New Jersey (or Basel, Switzerland). This strategic leadership role oversees global safety risk management for immunology compounds throughout the product lifecycle. The Sr. GPSTL will lead cross-functional safety operations and mentor a team of medical safety professionals while directly influencing benefit-risk evaluations and regulatory submissions.
Key Responsibilities
Lead medical safety for assigned immunology products across all development stages.
Provide expert clinical safety guidance to the Global Program Team (GPT), Clinical Trial Teams, and other cross-functional partners.
Oversee signal detection, risk management, and interpretation of internal and external safety data.
Guide the development of Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other regulatory safety documents.
Represent Medical Safety in health authority responses and global regulatory interactions.
Mentor and evaluate performance of Medical Safety associates, supporting career development.
Ensure compliance with GVP, ICH-GCP, and internal safety SOPs.
Required Skills & Qualifications
Medical degree (MD or equivalent) required; PhD, PharmD, or MPH in epidemiology preferred.
Board certification or specialty in immunology-related fields desirable.
Minimum 5 years postdoctoral clinical experience.
7+ years in drug development, with 5+ years in global safety leadership roles.
Strong knowledge of regulatory safety reporting, clinical safety assessments, and NDA/MAA submissions.
Proven ability to lead matrixed, multicultural teams.
Experience in safety issue resolution, medical writing, and scientific communication.
Strong command of global pharmacovigilance frameworks, benefit-risk evaluation, and immunology safety strategy.
Perks & Benefits
Salary Range: $204,400 – $379,600/year
Additional compensation: sign-on bonus, RSUs, and performance-based awards
Comprehensive healthcare (medical, dental, vision)
401(k) eligibility with company contribution
Paid time off including vacation, sick leave, and parental leave
Access to Novartis learning programs and global mobility options
Company Description
Novartis is a leading global pharmaceutical company dedicated to reimagining medicine. With a focus on immunology, oncology, and rare diseases, Novartis delivers cutting-edge treatments driven by science, patient-centric innovation, and rigorous clinical development.
Work Mode
On-site – East Hanover, NJ (or Basel, Switzerland)
Job Type: Full-time | Employment Type: Regular
Call-to-Action
Are you a passionate leader in drug safety ready to shape the future of immunology treatments? Join Novartis to drive global safety strategy and make a meaningful difference in patient care.
Apply today and advance your safety leadership career.
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