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Job: Senior Manager, Safety Assessment, Roivant Sciences, Inc., Durham, NC


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General Information

(3645260)

Job title: Senior Manager, Safety Assessment
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Job location: Durham, NC  27701 United States
Requisition code:
Date posted: 10/03/2017
Compensation:
Job category:Research and Development
Employment type:Full time
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Job Description


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The Senior Manager of Safety Assessment will support the safety assessment of potential compounds in various stages of development. Responsibilities include contributing to regulatory submissions (INDs, SPAs, IBs, etc); liaising with CROs to request bids/proposals to conduct nonclinical toxicology studies; managing generation of work orders/POs/invoices for contracted studies; qualifying CROs and monitoring pivotal studies; designing, reviewing and finalizing protocols of diverse nonclinical safety studies, managing/tracking timelines of studies; reviewing, interpreting and summarizing data to generate high quality reports for regulatory submissions to support clinical trials and marketing applications.

We are looking for a top quality individual with the following characteristics:

•Deeply motivated self-starter with an entrepreneurial spirit
•Desire to work in a quickly changing, fast-paced environment
•Unrelenting dedication to delivering quality results
•Being an integrity role model by visibly and consistently speaking and acting with superior moral values
•Willing to roll up your sleeves to get the job done
•Has an overall understanding and knowledge of diverse CROs
•Able to work with CRO personnel and gain their trust and respect
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Job Requirements


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•PhD preferred, or BS/MS with equivalent experience
•Toxicology board certification is a plus
•2-5 years pharmaceutical industry (or related industry), with knowledge and experience in aspects of drug development
•Proven ability to manage multiple projects/tasks at one time
•Excellent written and oral communication skills
•Broad knowledge of pharmaceutical toxicology and its related disciplines (e.g. DMPK, pharmacology, disease biology) and non-clinical drug development (e.g. Manufacturing, Clinical, Regulatory)
•Knowledge of drug development and life cycle management concepts and interdependencies with the overall development process
•Ability to design study protocols, analyze and interpret data for safety studies with minimal supervision
•Familiarity with GLP regulations and ICH, FDA and EMEA non-clinical safety guidelines
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