Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for our office in in Beerse, Belgium for a:
Principal Scientist, Nonclinical Safety Leader
The Nonclinical Safety Leader (NCSL) provides leadership within Nonclinical Safety (NCS) for all aspects of the global nonclinical safety development plan and its implementation for assigned projects in discovery and/or development. The NCSL is the single point of accountability within NCS to the Project Team and is the interface between the Project Team and NCS functional and senior management. NCS is responsible for the safety assessment of all modalities (e.g., small molecule, antibody-based, oligonucleotide, siRNA, and cell and gene therapies) within the Janssen R&D portfolio. In view of our expanding portfolio in new modalities, we are looking for NCSLs with a passion for one or more of these areas/modalities mainly focused on discovery and early development.
The NCSLs’ responsibilities include but are not limited to:
- Developing nonclinical safety strategies for novel modalities and/or routes of administration based on an integration of the literature, regulatory guidance, involvement with professional organizations and strong scientific acuity.
- Represents NCS on discovery and/or development project teams, being the single point of contact within NCS to the project team for assigned projects and the interface between the project team and NCS functional and senior management.
- Leads the development and maintenance of the NCS strategic plan for (early) de-risking and safety profiling in discovery and/or development, as well as the NCS project plans (activities, resource requirements, budget and timelines) for the assigned compounds.
- Leads the NCS team, comprising of NCS functional area scientist that support the progression of the assigned compounds.
- Responsible for the overall quality and timely delivery of projects for the project team.
- Accountable for all global regulatory preclinical documents (e.g. IB, CTA/IND, NDA/MAA, CTD and responses to regulatory agencies) for assigned projects.
- Represent NCS at interactions with global regulatory authorities.
- Responsible for due diligence activities on potential L&A candidates.
- PhD in toxicology, pharmacology, molecular biology or related field with at least 6 years pharmaceutical/biotech industry experience is require
- Experience representing toxicology/nonclinical safety on Project Teams is required.
- Strong in verbal and written communication and personal leadership skills, pro-active and flexible attitude, strong sense of urgency and scientific curiosity is required. Independent thinker, yet also an excellent great teammate. Experience in working in a matrixed and global environment
- Experience as a Study Director/Study Monitor conducting/monitoring toxicology studies under Good Laboratory Practice regulations is preferred.
- Post-doctoral training in toxicology, pharmacology or related field is preferred.
- Up to 10 % international travel is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.