[Hiring] Study Monitor-Principal Scientist, Translational Medicine/Preclinical Safety @Novartis

Role Description

The Preclinical Safety (PCS) department within the Biomedical Research (BR) - Translational Medicine Unit provides non-clinical safety strategy of products in discovery, development, and market, globally, with state-of-the-art regulatory compliance.

As a Scientific Study Monitor, you will join our PCS team to oversee non-clinical research activities for multiple projects across multiple disease areas for in-vivo toxicity and/or in-vitro screening toxicity studies conducted at our CRO partner sites as per the internal strategy and international standards, acting as the primary scientific contact for the Study Director.

Key Responsibilities:

• Formulates and leads/co-leads novel projects with team or enables matrix collaboration on project/technology solutions to achieve creative results for impact on BR goals.
• Generates innovative ideas within own team and/or project team/functional community to meet new technical requirements and/or answer project key scientific/technical/development questions.
• Establishes target dates and priorities to enable data-driven advancements in project teams, within own team, and with collaborators, or within functional community.
• Acts as the primary scientific contact for the Study Director at the Contract Research Organization (CRO).
• Oversees the progress of the study and ensures that the study is conducted, recorded, and reported according to the study protocol.
• Ensures compliance with GLP regulations, Novartis animal welfare policies, CRO in-house standard operating procedures, and all relevant international regulatory guidelines/regulations.
• Resolves study-related issues, liaises with internal experts, and informs the appropriate people in a timely manner.
• Strategically oversees and tracks study phases and sample delivery timelines to ensure timely internal contributor reports to the CRO.
• Forms strong working relationships with other Target team members through effective communication.
• Works closely with the PCS-Operations and PCS Project Team Member (PTM) to formulate a project outsourcing strategy.
• Has a working knowledge of HA regulations (Swiss medic, OECD, FDA) to support conduct of GLP compliant toxicology studies.
• May be PCS part-time PTM.

Qualifications

• PhD or MVSc/MS/M.Pharm with 7+ years of experience in drug discovery and/or development, preferably as 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 job and core areas.
• Working knowledge of tools and processes used in drug design and development.
• Excellent communicators, strong team players, and have a high level of logistical/planning ability.
• Registration and certification with one of the International Toxicology organizations.

Requirements

• This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.

Benefits

• Salary for Principal Scientist I: $119,700 - $222,300 per year.
• Salary for Principal Scientist II: $126,000 - $234,000 per year.
• Performance-based cash incentive and eligibility for annual equity awards depending on the level of the role.
• Comprehensive benefits package including health, life, and disability benefits.
• 401(k) with company contribution and match.
• Generous time off package including vacation, personal days, holidays, and other leaves.

Company Description

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.