Principal Biostatistician California-San Francisco
7/31/2015 2:01 PM

Initiates and leads statistical aspects in Phase I - IV clinical trial development. Leads the design and analysis of clinical trials. Maintains the statistical and analytical integrity of clinical trials analyzed. Primary statistician responsible for writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, and interpre  ...View Job
Associate Director, Regulatory Affairs California-San Francisco
7/16/2015 11:24 AM

Responsible for managing regulatory activities that support department and company projects and programs. Develops and ensures implementation of strategies and tactics for earliest possible approvals of drug filings and applications. Provides regulatory guidance and leadership to company and partner-sponsored project/program teams. Manages internal staff and external resources to ensure quality an  ...View Job
Manager, Medical Writing California-San Francisco
7/16/2015 11:12 AM

Responsible for supporting Clinical Development Lead in clinical protocol development, clinical study reports, Investigator's Brochures, IND/NDA. Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation and ensures documents are written in compliance with all regulations (ICH, GLP  ...View Job
AD, Research Biology California
7/16/2015 11:02 AM

We are seeking a highly motivated Associate Director/Director to lead the in vitro biology group at Nektar. The individual will develop cell-based and biochemical assays, emphasizing immunological methods to support our small molecule and biologics pipeline. This position requires a high degree of scientific curiosity and breadth, and a proven understanding of drug development in a fast-paced ma  ...View Job
Sr. Regulatory Affairs Specialist California-San Francisco
7/6/2015 2:39 PM

Position Summary Responsible for supporting the Regulatory Affairs Department across a number of company-sponsored projects. Under supervision, has primary responsibility for assembling regulatory dossiers for review by senior regulatory affairs management. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medic  ...View Job
Staff Statistical Programmer Analyst California-San Francisco
7/6/2015 2:25 PM

Position Summary Provide statistical programming expertise and hands on support to clinical projects across multiple therapeutics areas. Provide strong technical programming support to Biometrics and Data management and be a technical resource for statistical programmer analysts Contribute to activities in statistical systems development, validation and implementation including Standard Reportin  ...View Job
Principal Production Planner Alabama-Northern/Huntsville
7/5/2015 7:39 PM

Position Summary The Planner is accountable for developing and maintaining production plans for site manufacturing operations. Additionally, the Planner uses forecasts to create potential scenarios to analyze site capabilities and recommends changes to resources to adapt to prospective changes. The Planner requires close collaboration with Manufacturing, Program Management, Process Development,   ...View Job