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Nonclinical Safety Project Leader

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Job Description


Janssen Research and Development LLC is recruiting for an Associate Scientific Director, Nonclinical Safety Project Leader, located in La Jolla, CA or South San Francisco, CA.


The Nonclinical Safety Project 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 gene- and cell therapies) within the Janssen R&D portfolio. In view of our fast-growing portfolio in new modalities, we are in particular looking for NCSLs with expertise in gene- and cell and gene therapy, microbiome or ophthalmologic therapies, vaccines and/or have a passion for one or more of these areas/modalities.

Key Responsibilities:

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 acumen.
  • 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.

Qualifications
  • PhD in toxicology, pharmacology, molecular biology or related field with at least 6 years pharmaceutical/biotech industry experience is required
  • Experience representing toxicology/nonclinical safety on Project Teams is required.
  • Experience with nonclinical safety assessment of cell and gene therapy is preferred.
  • Post-doctoral training in toxicology, pharmacology or related field is preferred.
  • Diplomate of the American Board of Toxicology (DABT) is preferred.
  • Experience as a Study Director/Study Monitor conducting/monitoring toxicology studies under Good Laboratory Practice regulations is preferred.
  • 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 team player. Experience in working in a matrixed and global environment
  • Up to 10 % domestic and 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.


Primary Location
United States-California-San Diego-
Other Locations
North America-United States-California-South San Francisco
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
3747200206