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Job (this posting is now closed/inactive)


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General Information

(3645258)

Job title: Manager/Associate Director, Shared Services Development Operations
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Job location: Durham, NC  27701 United States
Requisition code:
Date posted: 08/01/2017
Compensation:
Job category:Research and Development
Employment type:Full time
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Job Description


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Our Development team is dedicated to successfully progressing investigational compounds through the phases of drug development to global approvals. With an extensive pipeline across various therapeutic area, the drug development team at Roivant is an integral part of one of the most innovative and exciting pharmaceutical companies in the world.

The nonclinical and clinical pharmacology units of Roivant Sciences are part of the “shared services” model of our company. These teams, located within the Roivant Sciences parent company, provide drug development support and serve as the nonclinical and clinical pharmacology departments for all the “Vant” companies. Without having to build out these units, it allows the “Vant” companies to focus on late stage clinical development and commercial functions.
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Job Requirements


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•Manage the portfolio of major initiatives across the nonclinical and clinical pharmacology units of the drug development organization
•Assist the nonclinical and clinical pharmacology units to provide an overview and timeline of cross-project deliverables
•Aid in requests/negotiations for proposals of nonclinical and clinical pharmacology studies, bid negotiations, and study awards from CROs
•Drive scheduling of study monitoring and CRO qualifications
•Track major milestone resourcing for regulatory submissions and meetings
•Develop ongoing reporting and ensure continuous dialogue amongst senior management to ensure projects and associated risks are well understood
•Ensure the quality of the overall portfolio/program through constant monitoring and control of departmental project plans
•Identify project and departmental resource requirements
•Drive a culture of on-time, on-budget project delivery
•Proactive communication of timelines to all appropriate personnel

Qualifications:
•BS/MS/PharmD/PhD with at least 5 years’ pharma or CRO experience
•Demonstrated ability to develop plans and timelines and lead teams to complete milestones and goals on time
•Proven ability to manage multiple projects/tasks at one time
•Familiarity with GLP/GCP requirements
•Demonstrated ability to identify, manage and mitigate risks
•Excellent written and oral communication skills
•Deeply motivated self-starter with an entrepreneurial spirit
•Desire to work in a quickly changing, fast-paced environment
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