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Knowledge of the drug development process and clinical research methodologies including experience in clinical trial design, data analysis/statistics and data interpretation; knowledge of regulations, ICH/GCP, adverse event management.
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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.
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MS degree required (preferably advanced doctoral level degree e.g., MD, PharmD, PhD), preferably in a health sciences related field with 8+ years of research related experience and/or pharmaceutical industry experience.
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Coordinate global COA/PRO strategic plans to support Early Development Teams (EDTs), Clinical Trial Teams (CTT), and/or Clinical Sub-teams (CST) in alignment with product franchise goals.
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GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.
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Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data in drug and vaccine development.
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Experience in scientific disciplines related to drug discovery and development, including biology, chemistry, toxicology, and pharmacology. Work with partners in Research and Tech and Onyx to ensure D&PS/Research Tech input into the design of an effective data reuse strategy for Research that maximises the value of GSK's data to drive research productivity and unlock upper quartile ambitions, working across D&PS and Research to drive uptake.
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Leads design, implementation and interpretation of the global clinical program for a drug candidate to deliver a successful regulatory submission worldwide through regulatory submission and approval (i.e., Phase 2, 3, pediatric and interventional Phase 4 studies)Works closely with early development to ensure alignment between early and late stage development strategy.
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Create clinical development strategies and delivery plans for investigational and marketed products according to the Therapeutic Area- and global Product strategy. Could you be our next Senior Director of Clinical Research and Development.
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Organon is a global leader in women’s health, delivering medicines and health technologies in the areas of reproductive health, maternal health and conditions that are unique to and disproportionately affect women.
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Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Bachelor Degree in Engineering, Automated Sciences, Computer Science, Biology, Chemistry or equivalent with scientific expertise with laboratory equipment in the development and execution of assays in a regulated bioanalytical environment.
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Providing global matrixed operational oversight and management of US and APAC employees, the Director provides expert engineering leadership and support of laboratory testing of medical devices, consulting engagements, development of content (e.g., technology hazards), and other device safety activities.
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FM Global helps clients maintain continuity in their business operations by drawing upon state-of-the-art loss-prevention engineering and research; risk management skills and support services; tailored risk transfer capabilities; and superior financial strength.
$44,500 - $64,100 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
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