Director Clinical Science

Hobson Prior - Cambridge, MA - Hobson Prior are looking for a Director Clinical Science to join a leading pharmaceutical organisation focused on recognising and developing new mechanism antibiotics for the treatment of serious infections. This is a permanent position that can either be based in Cambridge, Boston or Bay area. Job Responsibilities: To be accountable to ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study. Understand and support creation and support of competitor landscape, medical need, regulatory strategy. Ensure the high quality of protocol documents are developed aligned to the Clinical development plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe. Lead or Contribute as appropriate to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals and successful lifecycle management. Understand the clinical strategy, scientific interpretation of disease and target-based literature. Integrate data from internal, and external academic, conference, and competitor sources. Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development plan. Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents. Requirements: Requires a Bachelor of Science degree from an accredited educational institution. Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience preferred. At least 10+ experience in clinical development from early stage through to regulatory submission and market support. (of which, Phase III clinical development or NDA/EMA submission is essential). Experience in therapeutic areas of infectious diseases, internal medicine or multiple therapeutic areas preferred. Excellent skills in literature searches and summarizing literature. Excellent data analysis skills. Capable of analysing and succinctly and efficiently clinical information with strong written communication for development of clinical protocols/regulatory submissions including NDA/EMA dossiers. Proficiently in Excel, Power Point and Word. Experience in RAVE is preferred. Apply now: If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.... - Permanent - Full-time

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