Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Scientific Director, Established Products Nonclinical Safety Leader located in Spring House, PA or Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Nonclinical Safety Leader (NCSL) will provide toxicology leadership for a portfolio of approximately 40 Established Products. The NCSL will partner with other NCS scientists, Compound Development Teams and Established Products scientists to support drugs across several therapeutic areas, delivering world-class science-driven stewardship of Janssen’s late lifecycle products to enhance human health. Responsibilities include:
- Represent NCS on Established Products Compound Development Teams, being the single point of contact within NCS and the interface between Established Products scientists and NCS scientists
- Responsible for all global regulatory nonclinical documents for assigned Established Products including Annual Reports, Investigator Brochure updates, IND/CTA/NDA/MAA filings, updates to global labeling and Company Core Data Sheets, Risk Management Plans and responses to global regulatory agency queries
- Manage the NCS strategic and tactical plans for each Established Product (including oversite of resource requirements, budget and timelines)
- Contribute to Health Hazard Evaluations for emerging safety issues, potentially new pharmacovigilance signals or manufacturing changes (e.g., safety assessment of new impurities, degradants or excipients)
- Represent NCS at meetings with global regulatory authorities
- Responsible for assuring the appropriate prioritization, overall quality, and timely delivery of projects
- PhD in toxicology, pharmacology or related discipline, with at least 6 years pharmaceutical/biotech industry experience demonstrating progressively increasing responsibilities. Candidates with BS/MS degrees may also be considered if accompanied by appropriate additional years of experience is required.
- Experience in authoring nonclinical regulatory documents (e.g., Annual Reports, Investigator Brochures, IND/CTA/NDA/MAA, Company Core Data Sheets, Risk Management Plans) is required.
- Experience representing toxicology/nonclinical safety on teams is required- Question
- Experience as Study Director/Study Monitor conducting/monitoring toxicology studies under Good Laboratory Practice regulations and Diplomate of the American Board of Toxicology (DABT) certification are preferred.
- Experience with different therapeutic modalities such as small molecules, peptides and monoclonal antibodies is a plus.
- Strong in verbal and written communication and personal leadership skills, pro-active and flexible attitude and strong sense of urgency. Independent thinker, yet also an excellent team player. Experience connecting, crafting and delivering in a matrixed and global environment is required.
- 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
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)