Senior Clinical Scientist
PRA Health Sciences
Req #: 112503
Type: US-Southeast
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Overview: As a Senior Clinical Scientist, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: What you will be doing: * Development of protocols for clinical studies. * Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans * Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. * Responsible for providing clinical input into eCRF design, SAP, and TLFs. * Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends. . * Represent clinical development on project teams. * Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design. * Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies. * Serve as liaison to project teams, CRO's, Clinical sub-teams, and others. * Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest. Qualifications: You are: * Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred. * Minimum of 8 years of experience in research with at least 5 years of drug development experience are required. Alternative drug development experience will be considered * Prior IAI and/or Dermatology Drug Development experience is preferred. * Phase III experience required * Ability to work independently, multi-task, and work in a fast-paced environment. * Excellent written and oral communication skills. * Strong Analytical ability. * Ability to accommodate up to 20% travel or as business dictates What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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