Sr. Staff Scientist - Non-clinical Toxicologist

R.J. Reynolds Tobacco Company is the second-largest tobacco company in the United States. R.J. Reynolds is an indirect wholly owned subsidiary of Reynolds American Inc. (NYSE: RAI).

R.J. Reynolds Tobacco Company is seeking a non-clinical toxicologist to support current products as well as the development of new products consistent with RJRT's Growth, Innovation and Harm Reduction Platforms. The incumbent will be required to steward products under consideration to be in the company’s product portfolio, critically assess a broad range of toxicological information and make recommendations, design analytical and toxicological evaluation programs, develop technical documents on a variety of scientific and regulatory topics, and assist with the preparation of materials supporting regulatory submissions. The individual will be required to interact routinely with various internal and external groups and manage multiple projects to ensure R&D timelines are met. Specifically, this position will primarily consist of acting as a non-clinical toxicology study monitor responsible for overseeing the development and progress of studies, ensuring that studies are conducted, recorded and reported according to protocol and the Company’s objectives. The study monitor also provides oversight to ensure that studies are compliant with the appropriate GLP guidelines, as well as CRO and Company standard operating procedures.

* Design, manage, and interpret analytical and toxicological studies to support product development/stewardship and regulatory submissions. * Perform the role of study monitor for non-clinical toxicology studies, primarily in the framework of studies conducted globally by Contract Research Organizations (CROs). * Work closely with the internal client(s) to formulate nonclinical testing strategies, study design and timelines for completion. * Participate in the selection and qualification of applicable CRO(s) and manage the logistics of study initiation and conduct. * Manage the day-to-day scientific and non-scientific (i.e. budgets, schedules, etc.) aspects of the non-clinical studies and CRO performance. * Conduct and/or oversee onsite monitoring visits and technical/compliance audits and observe critical study phase procedures. * Ensure GLP compliance in all applicable studies.

* PhD or M.S. in Toxicology, Pharmacology or closely related discipline * PhD: Minimum of 5 years of industry experience conducting non-clinical toxicology studies in the tobacco, medical device, pharmaceutical, or chemical industries * MS: minimum of 8 years of industry experience conducting non-clinical toxicology studies in the tobacco, medical device, pharmaceutical, or chemical industries * Minimum 3-5 years of experience as a study director and/or a study monitor for non-clinical toxicology studies. * Training and experience in the conduct of non-clinical studies compliant with 21 CFR Part 58 and Part 11 and/or OECD regulatory requirements. * Ability to travel nationally/internationally. The Ideal Candidate will possess: * Excellent project management and teamwork skills. * Excellent interpersonal, written/oral communication skills. * Diplomat of the American Board of Toxicology (DABT) or equivalent. * Experience conducting non-clinical studies using tobacco smoke. * Experience with complex cell models and inhalation studies. * Ability to interact with and influence stakeholders to achieve positive outcomes related to study conduct and management.