Associate Scientist, Clinical Research
Posted on Feb 1, 2019 by Nektar Therapeutics
Participates in the execution of clinical, scientific research and product development activities.
Applies scientific principles and concepts to gather, extract, synthesize and present aggregate clinical data for review and evaluation. Oversees and develops clinical projects including component studies. Participates in developing input and development support for clinical plans and individual study protocols. Assists in developing statistical plans and performs preliminary and exploratory data analysis of completed clinical trials. Participates in the development of clinical operating guides and maintains secure study files. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Normally receives general instructions on routine work, detailed instructions on new assignments. Defines problems, develops approaches with sound judgment and some supervision. Puts work practices in context with larger team. Writes reports and protocols. Good clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way. Participating in internal pharmacovigilance committee meetings/signal detection meetings (including presentation of data). Ability to participate in and potentially manage multiple projects in a fast paced environment. Interfaces with various departments, customers and partners, and collaborates effectively with study and cross functional teams. Puts work practices in context with larger team. Coordinates activities with other team members. Assists in creation/revision of department procedures and policies.
An advanced degree (PharmD, PhD, RN) is required. Equivalent experience in Drug Safety/ Pharmacovigilance/ Clinical Science may be accepted. A minimum of 1 years work experience in Clincal or Development setting is required. Exceptional candidates without advanced degree with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be current in field, while able to demonstrate expert knowledge in scientific principles and concepts. Must be able to clearly communicate safety information both written and oral with minimal assistance. Must be able to compose sound written work with no assistance. Must possess good oral & written communication skills. Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus. Experience working MedDRA,with relevance to SAE analysis and SAE coding preferred. Experience working with WHODRUG dictionary, and familiarity with common Safety databases (e.g. ARISg, ARGUS,etc.) preferred. Experience working in an FDA regulated environment and knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing Safety reporting and processing for both clinical trial and post-marketing environments preferred. Previous supervisory skills are a plus. Must be willing to work as part of a team. Must demonstrate good interpersonal skills.
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Global Blood Therapeutics
University of California, San Francisco (UCSF)