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PAREXEL International
,
London, Greater London
Medical Director, Scientific Affairs
Overview
We're looking for a candidate to this position in an exciting company. Provides high quality and timely scientific services to internal and external customers Participates/liaises with scientific and regulatory consultants in PAREXEL providing drug development consulting services to clients. Provides expert consultative support for pharmacy services. Provides expert consultative support for regulatory affairs. Provides scientific and medical input in new awards Participate in the Risk Identification and Mitigation Process according to applicable Guidelines, including EMEA/CHMP/SWP/294648/2007 Rev. 1 Evaluate the Early Clinical Development Plan (Phase 1) for new compound and provides scientific guidance for sponsors, especially biotech companies. Reviews viability of proposed studies and provides advice on improving suitability of design for effectiveness, efficiency and ease of conduct. Secures new business awards with the Business Development and Business Operations team. Identifies, develops and maintains Sponsor relationships through Business Development activities such as client meetings, presentations and site visits. Excellent interpersonal skills. Detail oriented, with the ability to work creatively in a fast-paced environment Profound knowledge of clinical pharmacology. Profound knowledge and practical experience of applicable international and local guidelines and regulations (e.g. EMA, FDA, GCP, ICH). Good knowledge and practical experience with clinical drug development and experimental designs. Motivational abilities to assist business development and operations groups to achieve objectives (i.e. meet quarterly sales targets).