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Job: PhD Level Senior Scientist - Drug Development, RTI International, Research Triangle Park, NC


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General Information

(3698975)

Job title: PhD Level Senior Scientist - Drug Development
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Job location: Research Triangle Park, NC  27709 United States
Requisition code:
Date posted: 01/11/2018
Compensation:
Job category:Clinical Research
Employment type:Full time
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Job Description


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RTI International is currently seeking a Senior Scientist with a background and interest in drug development. This individual will fulfill a key role as member of a team of scientists in RTI’s Global Health Technologies Group working to develop new products to address critical unmet global health needs. The Senior Scientist will be responsible for the design and conduct of preclinical programs to support progression of novel therapeutic agents through the drug development process.

Responsibilities:

- Plan and oversee preclinical drug development activities (ie., toxicology, ADME, CMC, or regulatory) for drugs, biologics, or devices for clients.
- Provide drug development strategy and regulatory guidance for client’s projects.
- Develop and oversee execution of integrated drug development plans emphasizing strategically timed concurrent nonclinical, clinical, manufacturing, and regulatory activities.
- Prepare or assist in preparation of specified sections of regulatory documents and INDs and provide responses to regulatory authorities.
- Working with a project manager, ensure maintenance of each development program’s applications, documentation, per regulations.
- Oversee CRO and consultant activities and ensure deliverables are prepared or conducted on time and of high quality. Review study reports and related documents for compliance with regulatory requirements and good scientific principles.
- Communicate effectively with clients through oral or written presentations.
- Provides expertise and strategy to multi-functional project teams as a nonclinical specialist.
- Ensures compliance with GLP, GMP, and regulatory guidelines.
- Conduct internal (i.e., within RTI) and external business-development activities to raise profile of Global Health Technologies’ drug development capabilities. These activities will include the preparation of proposals for submission to funding agencies.
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Job Requirements


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Minimum Qualifications:

- MS degree in chemistry, toxicology, metabolism, biology or related field with 12 or more years of experience or PhD with 8 or more years of experience in drug development activities.
- Experience conducting, managing and/or monitoring nonclinical development activities, for example, reviewing/writing protocols and study reports.
- Experience in writing and reviewing CMC or nonclinical sections of regulatory submissions including IND briefing documents and IND applications.
- Familiarity with GLP requirements and ICH guidelines.
- Ability to lead and work as a member of multiple project teams.
- Excellent oral and written communications skills.
- Ability to lead and work as a member of multiple project teams, and negotiate and achieve consensus in diverse groups.
- Ability to prioritize and multi-task concurrent project demands.
- Candidates must be authorized to work in the United States.
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