Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Director, Translational Scientist, located in New Brunswick, NJ.
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.
As the Translational Scientist, you will support protocol design, preparation, and conduct of preclinical studies and assist with the preparation and review of reports, updates and regulatory submission documents for a medical countermeasure and Oncology program that is being funded by BARDA. You will take a leadership role for all work for this compound in the preclinical space as well as the translation of the preclinical science to clinical indications.
In collaboration with the Compound Development Team Leader and the Clinical leader, you will assist in the preparation of protocol and report writing and the operational execution of pre-clinical studies. You will closely interact with functional team members from the areas of translational research, clinical pharmacology, medical writing, regulatory, statistics, programming and clinical operations. Core responsibilities include:
- Leadership, planning, implementation and supervision of the preclinical studies at multiple labs to ensure study deliverables are met according to specified timelines, SOPs, budgets, quality oversight and resource allocation. This will require the mentorship and training of the preclinical lab staff to ensure they have the necessary guidance and tools for the performance of planned studies.
- Management of external service contracts and collaborations, including CRO activities and industry and academic collaborations for preclinical studies.
- Review and approval of study reports and summary documents for regulatory submissions from Pre-IND submission through NDA.
- Collaboration with regulatory, clinical, and drug safety to establish safety monitoring plans in clinical trials based on preclinical findings. This includes the integration of Safety, PK and PK/PD and efficacy assessments into study designs, protocols and the compound strategy.
- An advanced degree in a scientific discipline (i.e. M.S, Ph.D. or Pharm.D. or equivalent) with at least 5 years of experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry is required
- Significant knowledge of basic and clinical cancer research and its application to cancer drug development is preferred
- Comfortable interaction with both the compound and clinical team, with external labs and KOLs and the ability to perform effectively in a constantly changing environment.
- Strong communication skills are required and the ability to work effectively within a matrix team environment.
- Travel up to 15 % annually (international, as well as domestic).
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-New Jersey-New Brunswick-
Janssen Research & Development, LLC (6084)