Scientist, Clinical Research

Location
San Francisco, CA, United States
Posted
Oct 16, 2020
Ref
5208-515-R
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Scientist, Clinical Research to join their team.

Applies scientific principles and concepts to gather, extract, synthesize and present aggregate clinical safety data for signal detection review and evaluation.. Use of medical background and experience to integrate case-related information including medical conditions, lab results and procedures and effectively identify risks or risk factors. Maintains broad knowledge of global regulations and guidance as they apply to drug safety . Makes contributions to patient informed consent forms, CSRs, DSURs, IND Annual reports, integrated summaries of safety, Pharmacovigilance Plans, MAA/NDAs, EU Risk Management Plans, performing literature searches and evaluation, and other safety surveillance activities. 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 diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies. Normally receives no instructions on routine work, general instructions on new assignments. Synthesizes multiple data sources and draws general, non-obvious conclusions. Defines areas of inquiry, develops approaches and develops analyses with sound judgment with minimal supervision. Uses professional concepts and scientific knowledge to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways. Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way. Leading or actively participating in internal pharmacovigilance committee meetings/signal detection meetings (including presentation of data). Ability to 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. Writes complex reports and guidelines. May lead a small group, providing training as needed, and ensures adherence to company policies and quality requirements. Assists in creation/revision of department procedures and policies.

An advanced degree (MD, PharmD, PhD, RN) is required. Equivalent experience in Drug Safety/Pharmacovigilance may be accepted. A minimum of 2 years work experience in Drug Safety/Pharmacovigilance 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.