Study Monitor – Principal Scientist, Translational Medicine, Preclinical Safety

🔥 20 hours ago

🇺🇸 United States – Remote

💵 $119.7k - $234k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Novartis

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1996

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Novartis is an innovative medicines company dedicated to reimagining medicine to improve and extend people’s lives. With a presence in over 250 million patients worldwide, Novartis focuses on harnessing scientific breakthroughs to develop transformative, high-value treatments in areas such as cardiovascular, renal and metabolic diseases, immunology, neuroscience, and oncology. The company is committed to diversity, equity, and inclusion, and aims to create a positive impact through societal contributions and environmental sustainability efforts. Furthermore, Novartis engages in research collaborations and embraces modern technology platforms to advance their research and development capabilities, making them a leader in the global healthcare industry.

📋 Description

• Formulate and lead or co-lead novel projects and enable matrix collaboration on project and technology solutions • Generate innovative ideas to meet technical requirements and answer scientific, technical, and development questions • Establish target dates and priorities to enable data-driven project advancements • Oversee outsourced non-clinical research activities for multiple projects and disease areas • Act as the primary scientific contact for Study Directors at Contract Research Organization partner sites • Oversee study progress and ensure studies are conducted, recorded, and reported according to protocol • Ensure compliance with GLP regulations, Novartis animal welfare policies, CRO procedures, expert recommendations, and international regulatory guidelines • Resolve study-related issues and liaise with internal experts • Track study phases and sample delivery timelines • Ensure internal contributor reports are delivered to CROs on time and CRO reporting timelines are met • Build strong working relationships with Target team members • Work with PCS-Operations and PCS Project Team Members to formulate project outsourcing strategies • Apply working knowledge of Swissmedic, OECD, and FDA regulations to support GLP-compliant toxicology studies • Potentially serve as a part-time PCS Project Team Member

🎯 Requirements

• PhD or MVSc/MS/M.Pharm with 7+ years of experience in drug discovery and/or development • Preferably experience as a Study Director or Study Monitor in early preclinical screening and GLP studies • In-depth knowledge of toxicology assays in early development, safety pharmacology, and genotoxicity • Proficient with the full range of techniques used in the job and core areas • Working knowledge of tools and processes used in drug design and development • Excellent communication skills • Strong team-player abilities • High level of logistical and planning ability • Registration and certification with one of the international toxicology registries • Ability to work remotely anywhere in the U.S.; some restrictions may apply based on legal entity • Ability to meet working-hour and travel expectations defined by the hiring manager

🏖️ Benefits

• Performance-based cash incentive • Eligibility to be considered for annual equity awards, depending on role level • Health benefits • Life benefits • Disability benefits • 401(k) with company contribution and match • Vacation • Personal days • Holidays • Other leaves • Reasonable accommodations during the application process and for performing essential job functions

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